The most common source of confusion after lumbar surgery revolves around what kind of surgery a patient may have had.  And, in this case, any confusion is usually the result of confusing spinal decompression surgery - microdiscectomy or laminectomy - with spinal fusion surgery.

So here's what you need to know about post-operative care following lumbar surgery:

Wound Care After Lower Back (Lumbar) Surgery - For All Patients:
​
The sterile dressing applied in the Operating Room needs to be left in place for four to six days.  If there is a little blood on the dressing do not worry about it, but if the dressing becomes soaked or loose, it can be reinforced with a bulky cover dressing until it can be peeled away with clean hands and a new gauze pad placed over the surface dressing. Tape this back in place and keep it clean.

Do not get the dressing wet.  You may shower after three days, but cover the dressing with saran and tape and avoid directly soaking it.  DO NOT take a tub bath or submerge the wound in water until fully healed and sealed - 10 - 12 days.

After 4-6 days, you may remove the outer dressing and cover the inner dressing with gauze for comfort or leave open to air.

If you find a piece of suture protruding from the skin don't fiddle with it.  The surgical closure for my lumbar wounds, just as with my cervical incisions, is a plastic surgery closure with stitches that are absorbable.  The small knot tied on the skin will blow away after the stitches have resorbed.

If the wound is sore, you may place a bit of ice in a bag (a bag of frozen peas works great) for a bit to reduce swelling and pain.  Do not put ice directly on your skin.

At ten to twelve days the wound should be completely sealed and you can peel away or wash away any remaining dressing over the wound, or you can leave it to peel away on its own.
​
Slight bleeding from the wound may persist for 3 -5 days after surgery, but should then stop.  Continued drainage, drainage that starts up again after the wound appeared to seal, or swelling redness, or increasing pain at the incision site are all things I want to hear about, so please call the office early in the day before things become severe, or go to your emergency room for an examination.
​

For Lumbar Discectomy and Laminectomy Patients:

If you've had a discectomy, Microdiscectomy or laminectomy, without a fusion(this means the surgeon felt your spine was stable and back pain wasn't the biggest issue) follow these instructions.

Care and activity after a lumbar decompression surgery  is VERY DIFFERENT from care after a lumbar fusion!  I discuss these four points with every single patient I operate on.

1. After surgery, fusion patients do need to avoid back motion, and limit bending, lifting and twisting for several weeks, but the discectomy patient does not need to limit motion for as long or as completely, and they should start gentle range of motion as soon as they are comfortable (3-5 days).
2. After surgery, fusion patients may need to wear a rigid brace, full time, for several weeks, but the discectomy or laminectomy patient usually needs no brace, or may wear a soft corset for only three weeks before starting light activities.
3. After surgery, fusion patients need to avoid anti-inflammatory medications (NSAIDs) for eight to twelve weeks, but the discectomy or laminectomy  patient can take NSAIDs, and they can start using NSAIDs (Advil, Aleve, Ibuprofen, Naprosyn, etc) to treat back and muscular pain after the first week following surgery.
4. And finally - if fusion patients overdo it after surgery or don't follow instructions they can harm themselves, seriously affect their result, and end up needing more surgery.  If discectomy or laminectomy patients overdo it, get active too soon, or don't follow advice, they tend to make themselves sore, but they won't harm themselves or damage the spine unless they persist despite pain and against advice, in activities that subject them to heavy loads or repetitive bending and twisting.

 
Post-Operative Care for Lumbar Discectomy/Laminectomy Patients:

The first one-two weeks after surgery are about getting over the incisional pain.  Lumbar incisions traumatize a lot of muscle and muscular/incisional pain can be severe and can persist for weeks.

Patients should limit bending, lifting, and twisting activity during the first two weeks to avoid aggravating the healing wound and causing pain at the surgical site.  Standing, walking, and careful bending will not cause any injury or damage, but over-activity may aggravate incisional pain.  If that happens, the patient should back off, rest a bit, and ice the site before they get going again.
​
Back Brace: A corset is provided after lumbar disc surgery to wear while the incision is healing, but only for the first few weeks until muscle pain is under control. It is not used at night, when eating, or during light daily activities – gentle frequent motion is desirable. And after 3-4 weeks, we will want to have you take it off and start working on strengthening your back muscles!

Activities:

After discharge from the hospital - right from the start:
Every day, get up and walk three to four times every day– Walk briskly, fifteen to thirty minutes without stopping to sit down – indoors or out, as tolerated.  Bend carefully, but bend to put on your own slippers or shoes.  Limit lifting, but feel safe lifting and carrying 5 – 10lbs as needed.

After 7 - 10 days:
Increase daily walking, and start back to regular exercise on treadmill or exercise bike.  Start gentle range of motion exercise – flexion/extension and side bending – within the range of pain-free motion.

Increase normal bending and gentle twisting during light activities at home. 

When back motion is comfortable and you are no longer taking pain medications, you may start driving short distances. You may increase lifting and carrying up to 10 – 15 lbs as comfortable.

Add activities a little at a time, and don’t overdo it.  Change positions every half-hour. When you go back to a common activity, do a bit for 15 minutes then stop, rest, and reassess: If you're starting to stiffen up, knock off for the day.  If you feel good, you can take on more.

At three weeks:
Return to Dr. McLain’s Clinic for your post-operative x-rays and check-up.  Start light daily activities without restrictions.  Increase walking and exercise activities, and increase bending and lifting as tolerated for light activities in the house. 

Aerobic activity as tolerated – may start running if you like, increase cycling, or add a pool program.

At six weeks:
Return to Dr. McLain’s Clinic for your post-operative check-up.  If all is well, we’ll start home or formal Physical Therapy for the lower back and core strengthening, flexibility, and conditioning.

Recommended Physical Therapy Exercises After Week Four to Six for Cervical Total Disc Replacement Patients:
Daily activity, and a regular aerobic exercise program, are the keys to getting most people back to good function, and are important in all neck and back surgery patients.  Time invested in a physical therapy and exercise program is never wasted.
 
For Lumbar FUSION Patients:
​

​If you've had a Lumbar Fusion, (most often a Posterior Decompression and Fusion or TLIF) follow these instructions:
​

1. After surgery, fusion patients do need to avoid back motion for several weeks, and cannot start back range of motion until the fusion has had a chance to get started (4-6 weeks).
2. After surgery, fusion patients may need to wear a rigid back brace, full time, for several weeks, and should take it off only to bathe, and later when they sleep.
3. After surgery, fusion patients need to avoid anti-inflammatory medications (NSAIDs) for eight to twelve weeks, as these medications (Advil, Aleve, Ibuprofen, Naprosyn, etc) can interfere with the fusion.
4. And finally - if fusion patients overdo it after surgery or don't follow instructions they can harm themselves, seriously affect their result, and end up needing more surgery.  Pushing forward too fast, cheating on brace-wear or restrictions, or cigarette smoking increases the risk of a non-union (pseudarthrosis) or can even cause the fixation implants to loosen or break.  That would mean more surgery.

 
Post-Operative Care for Lumbar Fusion Patients:
The first one-two weeks after any surgery are dedicated to getting over the post-operative pain.  Patients should limit activity to avoid aggravating the healing wound and causing pain at the surgical site, and to avoid stressing the fusion before it has had a chance to get started. 

Standing, walking, and careful bending will not cause any injury or damage, but over-activity may aggravate incisional pain or slow or disrupt the early fusion, which can lead to a surgical failure.  Patients can safely bend to put their socks and shoes on, but must avoid repetitive bending, lifting, and twisting.

Activities:
After discharge from the hospital - right from the start:
Every day, get up and walk three to four times every day– Walk briskly, fifteen to thirty minutes without stopping to sit down – indoors or out, as tolerated.  Bend carefully, but bend to put on your own slippers or shoes.  Limit lifting, but feel safe lifting and carrying 10 – 15lbs as needed.

After 7 - 10 days:
Increase daily walking, and start back to light exercise on treadmill or exercise bike.  Do not start trying back exercises or back range of motion exercises yet.
​
Increase normal bending and twisting of the lower back during light activities at home.  

At three weeks:
Return to Dr. McLain’s Clinic for your post-operative x-rays and check-up.  Start light daily activities with restrictions.  Increase walking and exercise activities, and increase bending and lifting as tolerated for light activities in the house.  Continue wearing your collar as instructed.  Patients with a desk or phone job can work from home or be driven to work for light duty as tolerated. 

Aerobic activity as tolerated – may start treadmill or elliptical exercise if you like, increase stationary cycling, but cannot add a pool program that involves swimming until fusion is solid and range of motion is restored.

At six weeks:
Return to Dr. McLain’s Clinic for your post-operative check-up and more x-rays.  If all is well, we’ll start weaning you out of the back brace and plan to start a formal Physical Therapy Program for back and core strengthening, flexibility, and conditioning for week eight to ten.

Recommended Physical Therapy Exercises After Week Eight to Ten for Cervical Fusion Patients:
Daily activity, and a regular aerobic exercise program, are the keys to getting most people back to good function, whether they've had a disc removal, a lumbar fusion, or treatment for a fracture or other disorder.

You can learn more about disc replacement surgery, and other types of spine surgery and treatment, by checking out more sections of this website, or find me on Linkedin or Facebook at Robert McLain MD.  Thanks!
​

Usually these are questions that were addressed at one point or another before or after the operation, but there's a lot to digest so some of the finer points can be easily forgotten.  More often, my patients remember what I told them, but get conflicting instructions from someone else - the recovery room nurse, the scheduler, a family member or next door neighbor! - who tells them firmly "Oh No No No - you can't do THAT, you have to do THIS" and gets them confused and upset.

The MOST COMMON source of confusion is advice or instruction, provided by a nurse or health care provider, that's intended for a patient who had a completely different kind of surgery.  And, when it comes to cervical spine surgery the confusion is usually between Cervical fusion and Cervical disc replacement.

First of all, each of my patients should get a PRINTED handout with the most simple instructions, given at the time of discharge, specific to their treatment and my recommendations.  If you aren't offered this, ask for it, it's available.
​
Second, follow the instructions I provide you which are specific to your condition and your kind of surgery -

So here's what you need to know:

Wound Care After Neck Surgery - For All Patients:
The sterile dressing applied in the Operating Room needs to be left in place for three to four days.  If there is a little blood on the dressing do not worry about it, but if the dressing becomes soaked or loose, it can be peeled away with clean hands and a new gauze pad placed over the surface dressing. Tape this back in place and keep it clean.

Do not get the dressing wet.  You may shower after three days, but cover the dressing with saran and tape and avoid directly soaking it.  DO NOT take a tub bath or submerge the wound in water until fully healed and sealed - 10 - 12 days.

After 3-4 days, you may remove the outer dressing and cover the inner dressing with gauze for comfort or leave open to air.
 
If you find a piece of suture protruding from the skin don't fiddle with it.  The surgical closure for my wounds is a plastic surgery closure and the stitches are absorbable.  The small knot tied on the skin will blow away after the stitches have resorbed.

If the wound is sore, you may place a bit of ice in a bag (a bag of frozen peas works great) for a bit to reduce swelling and pain.  Do not put ice directly on your skin.

At ten to twelve days the wound should be completely sealed and you can peel away or wash away any remaining dressing over the wound, or you can leave it to peel away on its own.
​
Slight bleeding from the wound may persist for 3 -5 days after surgery, but should then stop.  Continued drainage, drainage that starts up again after the wound appeared to seal, or swelling redness, or increasing pain at the incision site are all things I want to hear about, so please call the office early in the day before things become severe, or go to your emergency room for an examination.

For Cervical Total Disc Arthroplasty Patients:

If you've had a Cervical Disc Replacement, (remember, this operation is also call a cervical disc arthroplasty or artificial disc) follow these instructions.

Care and activity after a cervical disc replacement is VERY DIFFERENT from care after a cervical fusion (ACDF)!  I discuss these four points with every single patient I operate on.

Healthcare providers (nurses/doctors/PT's/family members) make the following mistakes constantly:

1. After surgery, fusion patients do need to avoid neck motion for several weeks, but the disc replacement patient does not need to keep their head still, and they should start gentle range of motion as soon as they are comfortable (2-3 days).
2. After surgery, fusion patients do need to wear a rigid cervical collar, full time, for several weeks, but the disc replacement patient wears a soft cervical collar for only five to seven days and should then take it off and put it away.
3. After surgery, fusion patients need to avoid anti-inflammatory medications (NSAIDs) for eight to twelve weeks, but the disc replacement patient can and should take an NSAID daily, and they should start using NSAIDs (Advil, Aleve, Ibuprofen, Naprosyn, etc) to treat neck and muscular pain after the first week following surgery.
4. And finally - if fusion patients overdo it after surgery or don't follow instructions they can harm themselves, seriously affect their result, and end up needing more surgery.  If disc replacement patients overdo it, get active too soon, or don't follow advice, they may make themselves really sore, but they won't harm themselves or damage the implant, and they will just need to back off, use ice and NSAIDs, and limit activity until  they are comfortable again.

 
Post-Operative Care for Cervical Total Disc Arthroplasty Patients:
​
The first one to two weeks after any surgery are dedicated to getting over the incisional pain.  Patients should limit range of motion and activity a little bit to avoid aggravating the healing wound and causing pain at the surgical site.  Standing, walking, and careful bending will not cause any injury or damage, but over-activity may aggravate incisional pain.  If that happens, the patient should back off, rest a bit, and ice the site before they get going again.
Cervical Collar: A collar is provided after cervical disc replacement to wear while the incision is healing, but only for the first 5-7 days. It is not used at night, when eating, or during normal daily activities – gentle frequent motion is desirable. And after 5-7 days, take it off and put it in the closet!
Activities:
                After discharge from the hospital - right from the start:
Every day, get up and walk three to four times every day– Walk briskly, fifteen to thirty minutes without stopping to sit down – indoors or out, as tolerated.  Bend carefully, but bend to put on your own slippers or shoes.  Limit lifting, but feel safe lifting and carrying 5 – 10lbs as needed.

After 7 - 10 days:
Increase daily walking, and start back to regular exercise on treadmill or exercise bike.  Start gentle range of motion exercise – flexion/extension, side bending, right and left rotation – within the range of pain-free motion.

Increase normal bending and twisting during light activities at home. 

When neck motion is comfortable and head can turn to look over each shoulder patient may start driving short distances. May increase lifting and carrying to 10 – 15 lbs as comfortable.

Add activities a little at a time, and don’t overdo it.  With cervical surgery prolonged sitting with head in one fixed position - reading, watching TV, working at the computer – can result in stiffness and pain.  Change positions every half-hour.

At three weeks:
Return to Dr. McLain’s Clinic for your post-operative x-rays and check-up.  Start light daily activities without restrictions.  Increase walking and exercise activities, and increase bending and lifting as tolerated for light activities in the house. 

Aerobic activity as tolerated – start running if you like, increase cycling, or add a pool program.
Start gentle isometrics exercises for neck strengthening and start shoulder shrugs and shoulder rolls with 5 - 10 pounds in each hand, twice a day as tolerated.

At six weeks:
Return to Dr. McLain’s Clinic for your post-operative check-up.  If all is well, we’ll start home or formal Physical Therapy for upper back and shoulder girdle strengthening, flexibility, and conditioning.
​
Recommended Physical Therapy Exercises After Week Four to Six for Cervical Total Disc Replacement Patients:
Daily activity, and a regular aerobic exercise program, are the keys to getting most people back to good function, and are important in all neck and back surgery patients.  Time invested in a physical therapy and exercise program are never wasted.


​For Cervical FUSION Patients:

If you've had a Cervical Fusion, (most often an Anterior Cervical Discectomy and Fusion or ACDF) follow these instructions.
Healthcare providers (nurses/doctors/PT's/family members) usually know more about fusion than disc replacement and ar usually going to give you the following instructions correctly:

1. After surgery, fusion patients do need to avoid neck motion for several weeks, and cannot start neck range of motion until the fusion has had a chance to get started (4-6 weeks).
2. After surgery, fusion patients do need to wear a rigid cervical collar, full time, for several weeks, and should take it off only to shave or bathe, and later when they eat.
3. After surgery, fusion patients need to avoid anti-inflammatory medications (NSAIDs) for eight to twelve weeks, as these medications (Advil, Aleve, Ibuprofen, Naprosyn, etc) can interfere with the fusion.
4. And finally - if fusion patients overdo it after surgery or don't follow instructions they can harm themselves, seriously affect their result, and end up needing more surgery.  Pushing forward too fast, cheating on brace-wear or restrictions, or cigarette smoking can lead to a non-union or even cause the fixation implants, such as cervical fixation plates, to loosen or break.  That would mean more surgery.

Post-Operative Care for Cervical Fusion (ACDF) Patients:

The first one-two weeks after any surgery are dedicated to getting over the incisional pain.  Patients should limit activity to avoid aggravating the healing wound and causing pain at the surgical site, and to avoid stressing the fusion before it has had a chance to get started.  Standing, walking, and careful bending will not cause any injury or damage, but over-activity may aggravate incisional pain or initiate a surgical failure.  You can safely bend to put your socks and shoes on, but avoid repetitive bending, lifting, and all twisting.

Cervical Collar:
A hard or soft collar is provided after cervical fusion depending on the type of instrumentation used and your bone quality.  During the first 3 weeks this brace is to be worn full time, including  at night, when eating, or during normal daily activities – and any motion of the head and neck should be avoided when the collar is taken on or off.  And after 3 -6 weeks, we will start weaning you out of the brace, but you should never take it off and put it away just because you "Feel ok"!

Activities:
After discharge from the hospital - right from the start:
Every day, get up and walk three to four times every day– Walk briskly, fifteen to thirty minutes without stopping to sit down – indoors or out, as tolerated.  Bend carefully, but bend to put on your own slippers or shoes.  Limit lifting, but feel safe lifting and carrying 5 – 10lbs as needed.

After 7 - 10 days:
Increase daily walking, and start back to light exercise on treadmill or exercise bike.  Start gentle shoulder range of motion exercise – shoulder shrugs – within the range of pain-free motion. Do not start trying neck exercises or neck range of motion exercises yet.

Increase normal bending and twisting of the lower back during light activities at home. 

At three weeks:
Return to Dr. McLain’s Clinic for your post-operative x-rays and check-up.  Start light daily activities with restrictions.  Increase walking and exercise activities, and increase bending and lifting as tolerated for light activities in the house.  Continue wearing your collar as instructed.

Aerobic activity as tolerated – may start treadmill or elliptical exercise if you like, increase stationary cycling, but do not try to add a pool program that involves swimming until out of the collar and limber.

At six weeks:
Return to Dr. McLain’s Clinic for your post-operative check-up and more x-rays.  If all is well, we’ll start weaning you out of the collar and plan a formal Physical Therapy Program for upper back and shoulder girdle strengthening, flexibility, and conditioning.

Recommended Physical Therapy Exercises After Week Eight to Ten for Cervical Fusion Patients:
Daily activity, and a regular aerobic exercise program, are the keys to getting most people back to good function, whether they've had a disc replacement, a cervical fusion, or a posterior cervical operation.
​
I hope that answers all your important questions!  Thanks for reading and feel free to share with anyone you think might benefit.  If you like the content, let me know what other questions you might have!

In the studies I participate in, like the ongoing SMART trial sponsored by Centinel Spine and carried out under the strictest FDA guidelines, the implant devices are not new to the market - they have been in use for years, sometimes more than a decade, outside the US or for more limited application in the US, and have already passed several levels of clinical validation and safety testing.  For instance, in the ongoing SMART trial for two-level cervical disc replacements, one of the "test" implants (C-Vivo) has been in use since 2009, and has been used over 25,000 times around the world before being selected for the ongoing two-level study. ​

​In fact, that implant is FDA approved for single level use in the US at this time.  The other study implant (C-SK) is a modification of the FDA approved device that has been used for single level disc replacement in the US for the last 15 years, with over 100,000 successful implantations.  And the Control device?  That is the Mobi C implant that is one of the most widely used disc replacement devices in the world, and the implant I use almost exclusively for two-level surgery for all other patients.

The SMART Trial itself is very specific, and it's studying a procedure that, currently, is not an option for most patients.  The only patients that could participate are those with two-level cervical disc herniations or disc degeneration, with persistent neck and arm pain severe enough to warrant surgical care.  The trial isn't for patients with a single level disc herniation, and it can't include patients with several levels of degeneration, a previous fusion, or such severe disc disease that the spine has become rigid or deformed.  There are good treatments for those problems, but the clinical trial isn't the place for those patients. 

Patients in the SMART Trial are randomized to one of two treatment groups.  Both groups get exactly the same preoperative and post-operative care and follow-up, but one group will get the Study Implants (prodisc C Vivo or prodisc C SK) and one group will receive the Mobi-C implant at the time of surgery.

The technique for surgery is the same, the surgical time is the same and the post-operative care and activity levels are the same.  Patients that don't care to enroll in the study, or don't qualify, will still get the same preoperative care and preparation as any surgical patient, and if they choose to go through with disc replacement surgery, they will receive the same Mobi-C implants at the time of their surgery, delivered in the same way.

The further advantage for some patients is that, if they are having trouble getting approval for surgical treatment because of insurance or other issues, the study sponsor will often cover some or all of the costs of treatment and follow-up.  This means that any patient that is indicated for the surgery and motivated to participate can have an opportunity regardless of their financial status or insurance situation.

Is a clinical trial right for you? It depends on what you are suffering from, and what your circumstances are, to some extent, but it always depends on whether you are comfortable with the study and really want to participate.  If you are interested in this study, I'd invite you to contact my study coordinator, Jayson Zadzilka, or call 330-205-1334.

Newer technologies or materials can sometimes eliminate these weaknesses without much change in the base design, but may still require an extensive study before being "approved" by the FDA for distribution.  The willingness to accept the theoretical  risk of a well studied newer technique in order to avoid the known risks of an existing treatment is one reason a patient may at least consider their options.
​
In other cases, advances in engineering or material science make the reliability of the newer implant considerably better than the existing product, which may have been designed decades ago and remain essentially unchanged for many years.  Newer technologies, such as 3-D printing, have so changed the ability to fabricate a metal implant that the whole design and technique for implant placement may change, and may require renewed trials.

And, naturally, after any implant or technique has been in use for several years, surgeons and designers recognize ways to improve it and to eliminate problems that may have emerged after thousands of cases or many years.  Simply changing the surface texture or the base material of an original design may require resubmission, and real changes in structure or geometry almost always will.  Again, wanting the upgraded design rather than the old standard is important to many patients.

​Why are these studies even necessary?
Recent failures of some very promising hip replacement implants drove the FDA to increase their demands on manufacturers.  Companies developing and producing Orthopaedic implants, here or overseas, now have to show the FDA that a new implant is backed up by valid scientific evidence showing that it is safe and effective for its intended use. The FDA also requires implant companies to get the agency’s approval before making any changes to the implant, its labels, or even what metals are used and how it’s manufactured. Manufacturers have to report the ongoing safety results of these implants to the FDA every year.

Prior to these current requirements, for instance, metal-on-metal total hip replacement implants were cleared through a different process. Manufacturers did not have to prove their new design was safe and effective, merely show that it was “substantially similar” to a proven device already on the market. 

However, manufacturers stopped making and distributing the metal-on-metal hip implant products and issued extensive recalls after thousands of patients developed a complication called metallosis, a reaction to metal particles rarely seen after Orthopaedic procedures prior to the use of metal on metal hip joints.  Because metallosis didn't become apparent until years after the implants were put in, that meant that thousands of patients suffered injuries and required revision surgery to replace the hips.

As of March 2019, there are no metal-on-metal hip replacements approved for use in the United States.
 
What does a patient have to do if they agree to participate in a Clinical Trial?
They have to fit the INCLUSION CRITERIA - they have to be of the right age, with the right kind of problem, and the right symptoms to qualify for the procedure being studied.  For the ongoing SMART spinal implant study, that means having a relatively specific kind of problem in the right part of the spine - a one or two level disc herniation or degeneration in the cervical spine, for instance.  

They can't fit any of the EXCLUSION CRITERIA - complicating medical problems such as poor bone quality, infections or tumors, heart or lung disease, for instance, have had previous surgery, be pregnant or plan on becoming pregnant (sometimes) during the course of the treatment, or be of the "wrong" age or gender, if age or gender are a critical issue in the study.  Patients may be excluded from the study if they have too much disease - degeneration at many levels of the spine, or such bad arthritis that the spine has become rigid or deformed, for instance, but should never be excluded because of their ethnicity, background, or social circumstances.

They must WANT TO participate - no study like this is ever intended to coerce a patient into participation!  No matter what the circumstance, patients can choose to participate, or to leave the study anytime they wish.  On the other hand, any time a patient stops participating, they are counted as a failure for their treatment group, so it's important that the study only enrolls patients that really understand their obligations and really want to participate.

They must be able to FOLLOW-UP at the appropriate times after the study so that their results can be accurately assessed and recorded. That means patients that have to travel long distances for visits, or who are planning to move out of the area after surgery, or have other issues that make their regular return unlikely, aren't good candidates for inclusion in most studies.  Many studies do provide compensation for time and travel to help patients make it to their important follow-up visits.

They must be comfortable with the decision process that will determine which treatment they will receive.  In studies of Orthopaedic and spinal implants, the comparison of two different implants often involves a RANDOMIZATION process which determines that the group of patients getting Implant A is as similar to those receiving Implant B as possible.  Randomization is usually carried out by someone other than the surgeon or study team, so that there is as little bias in the process as possible.  This process is often "blinded" such that the patient won't know until later in the study which implant they received, and sometimes from the study team until the day of surgery.  This insures that every patient gets the same care and attention though-out their care, no matter which group they are in.

For more information about patient participation in FDA approved Clinical Trials go to: Clinical Center NIH

Thanks for reading. Let me know if you have other questions about clinical trials or spine surgery in general!

A Clinical Trial is a very common type of research study to determine the safety and effectiveness of a new treatment or type of implant, usually in comparison to the already established standard of care.  The study is usually a very carefully monitored process, and most surgical trials are monitored by the Food and Drug Administration (FDA) or similar agency to insure that the patient's safety and health are carefully protected.

​But it's still "experimental", right?

To some extent, whenever you try to answer a question of "Is Implant A better than Implant B?" or "Does Drug #1 work as well as Drug #2?" you are performing an experiment.  However, depending on how much research work has been done prior to asking that question, investigators may have almost certainty about the answer, or at least know that the answer won't be "worse than" the standard of care ("Standard of Care" is the most universally accepted treatment currently available).

There are some situations where the certainty of the outcome isn't assured: treatment of serious and frequently lethal disease, like some cancers, may warrant a trial of a new chemotherapy or other treatment that hasn't been widely tested before, particularly if what is already available is known to be of limited value.  In those cases, patients - and their doctors, -  may be willing to take the risk that the new treatment may have a side effects because they know that the existing treatments just aren't very successful.

For less dire circumstances, such as for treatment of back pain or neck pain, new treatments are constantly being proposed and evaluated in smaller studies, but by the time a large Clinical Trial is proposed, there is usually a large body of evidence that

-  1. The new treatment is at least as good as existing treatments;
-  2. The new treatment is as safe as the existing treatments; and
- 3. The new treatment provides results that won't deteriorate or cause harm over the foreseeable life of the implant or treatment.

Not all new products or procedures go through a formal clinical trial before reaching the market, and some physicians and surgeons will offer treatment with implants or applications that are "off-label", or - in other words - not specifically approved by the FDA for the use being recommended.  This is not always a reckless or questionable approach.  For instance, for years the most commonly used hip replacement implants were used "off-label" because hip replacement was known in clinical practice to be so much better than the alternatives (hip fusion) that it would have been unethical to ask some patients to go through the older and clearly inferior treatment as part of a trial.  But that's what would have been required to generate a useful experimental proof.

In that sense, no-one has ever proven that parachutes are really useful.  There's lots of clinical evidence, but you can't really prove it because you can't find anyone for the control group - people willing to jump out of the plane without a parachute!  So surgical trials are designed and strictly overseen to make sure that neither treatment group is exposed to a known and unnecessary additional risk.
​
If a company wants to have the approval of the FDA to market a new device or technique for a specific disease or problem in the US, one of the final steps in insuring that the product is safe and satisfactory is to invite patients to enroll in a study (Clinical Trial) that will compare the new implant or technique to the most widely accepted and carefully validated option currently available, (Standard of Care).  Before such a study is initiated, the new device has usually been through extensive laboratory testing, materials testing, cadaver experiments, and fatigue testing, and in many cases has already been in use in other parts of the world, sometimes for years.  In some cases the new device is already FDA approved for use in the United States, but hasn't been used in the proposed technique before.  Either way, there may 10's of thousands of surgical cases already available for review and analysis before a Multicenter Clinical Trial can be approved.

So, even though any investigation or Clinical Trial has some aspect of experimentation to it, the risks have been minimized to the extent that the reward of participation may far outweigh that risk.

If you want to know more about any clinical trial you've read about or been offered participation in, you can learn all about the study and others like by going to
  https://clinicaltrials.gov/ct2/show/NCT04012996..

Thanks for reading. Let me know if you have other questions about clinical trial or spine surgery in general!