Peroneal Palsy (Foot Drop)NCT02856958
Acute Nerve Decompression Versus Non-operative Treatment for Peroneal Nerve Palsy Following Primary Total Knee Arthroplasty
A study testing Nerve decompression and Non-operative in people with Peroneal Palsy (Foot Drop), run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare acute nerve decompression versus nonoperative treatment in the management of peroneal nerve palsy after total knee arthroplasty (TKA). We hypothesize that acute nerve decompression patients will have better long-term outcomes to patients treated non-operatively for peroneal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peroneal Palsy (Foot Drop)
- What is being tested?
- Nerve decompression and Non-operative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient presenting with peroneal palsy (< 3/5 dorsiflexion) within 3-weeks after primary TKA
Who cannot join
- Patient's with pre-existing peroneal palsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Orthopedics at Rush
Chicago, Illinois, 60612
About this study
The purpose of this study is to compare acute nerve decompression versus nonoperative treatment in the management of peroneal nerve palsy after total knee arthroplasty (TKA). We hypothesize that acute nerve decompression patients will have better long-term outcomes to patients treated non-operatively for peroneal nerve palsies after TKA.
Read the detailed description
Peroneal nerve palsy after TKA has been reported in the literature to be 0.3% to 1.5%, although it can be as high as 9.5%. Several risk factors have been described: preoperative valgus deformity and flexion contracture, prolonged intraoperative use of a tourniquet, use of epidural anesthesia, and rheumatoid arthritis. Peroneal palsy is rarely diagnosed on postoperative day 0, but in more than 85% of cases, it presents prior to postoperative day 4.Initial treatment should include flexing the knee, removing any compressive bandages, and discontinuing epidural anesthesia. When there are residual deficits, supportive measures are initiated, including application of an ankle-foot orthosis and physical therapy to prevent ankle contracture. If there is no clinical recovery by six to twelve weeks, electromyography (EMG) is typically performed. Some clinicians have advocated the use of EMG studies in the acute phase. In cases of incomplete recovery, delayed surgical exploration and decompression of the peroneal nerve is an option that has been reported to improve outcomes. Unfortunately, not all cases respond, even with surgical treatment. In addition, little information is available describing the outcomes of acute surgical decompression for peroneal nerve palsy after total knee arthroplasty.
While there have been retrospective case reports and series that have examined outcomes after delayed peroneal nerve decompression, we are unaware of reports describing acute decompression. Delayed decompression of the peroneal nerve has been associated with the return of nerve function. Krackow et al. reported the results of five patients who underwent delayed surgical decompression for peroneal nerve palsy after total knee arthroplasty at an average of 27.2 months (range, 5-50 months) and found that 100% were able to discontinue use of the ankle-foot orthosis and 80% had full neurological recovery. The patient who had partial return of neurological function did not undergo decompression until almost four years postoperatively. Mont et al. found that, in patients who underwent surgical peroneal nerve decompression two to sixty months following total knee arthroplasty, 97% reported functional and subjective improvements at a mean of three years post-decompression and were able to discontinue use of the ankle-foot orthosis. Only 33% of the patients who were managed nonoperatively reported improvement in functional and subjective outcomes.
Therefore, in 33% of the patients, an acute decompression would not have been necessary, but in the other 67%, it may have been beneficial. In both studies, patients underwent a trial of nonoperative treatment, and no patient underwent a peroneal nerve decompression earlier than two months after the index total knee arthroplasty. Initial experience with two peroneal nerve palsies following TKA has encouraged some institutions to offer acute decompression to all patients who present with peroneal palsy following total knee arthroplasty. This parallels the practice patterns regarding the wrist, where an acute carpal tunnel release is performed to avoid complications when a patient demonstrates carpal tunnel compressive symptoms postoperatively from wrist surgery. While most patients will improve with nonoperative treatment over time, acute decompression may accelerate recovery, which can decrease uncertainty and stress for both the patient and the surgeon. The surgical technique is relatively straightforward; however, the surgeon and patient must consider the risks of a second anesthetic and operation. In previous experiences with both acute and delayed decompression, while direct damage to the nerve itself is rare, fascial bands, hematomas, and local edema are typically identified that contribute to the compression of the peroneal nerve. Therefore, while nonoperative treatment would possibly result in a return of nerve function once the hematoma resorbed and edema decreased, there may still be some residual dysfunction from the time period of nerve compression and thickened fascial bands around the nerve. Additional study of acute decompression is warranted to understand if it offers both short and long-term advantages over nonoperative treatment.
Treatment Groups: Acute Nerve Decompression - patients will initially receive conservative management (flexing the knee, removing any compressive bandages, and discontinuing epidural anesthesia) followed by a peroneal nerve decompression within 1 week of diagnosis of peroneal nerve palsy. Decompression involves surgical intervention in the setting of a sterile operating room. The patient will be provided with multiple options of anesthesia (per discussion with the anesthesia team). The surgical procedure involves an incision at the lateral aspect of the knee, near the proximal fibula at the level of the fibular neck. The peroneal nerve is carefully identified and dissected. Tissue surrounding or impinging the nerve is carefully removed or cut to rid the compressive environment. The nerve is re- examined to ensure there are no additional points of compression/irritation. The soft-tissues and skin are subsequently closed with suture. Nonoperative Treatment - patients will receive conservative management (flexing the knee, removing any compressive bandages, and discontinuing epidural anesthesia) as well as supportive measures (ankle-foot orthosis and physical therapy) for symptoms lasting longer than 6 week. Outcome Measures: Primary Measure - ≥ 3/5 dorsiflexion strength 3 months after surgery/randomization
- Conditions
- Peroneal Palsy (Foot Drop)
- Being tested
- Nerve decompression, Non-operative
- Medical subject headings
- Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve decompressionProcedure or surgery
Non-operativeOther
Physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Operative | Experimental | Peroneal nerve decompression Receives: Procedure: Nerve decompression |
| Non-operative | Active comparator | Physical therapy Receives: Other: Non-operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dorsiflexion strength
Measured: within 3 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peroneal Palsy (Foot Drop)Studies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John J Fernandez, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856958
- Sponsor's protocol ID
- 16041403
- Status last verified
- Apr 2018
- First submitted
- 2 Aug 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Nerve Decompression Versus Non-operative Treatment for Peroneal Nerve Palsy Following Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02856958
- Acronym / sponsor ID
- 16041403
- Conditions
- Peroneal Palsy (Foot Drop)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare acute nerve decompression versus nonoperative treatment in the management of peroneal nerve palsy after total knee arthroplasty (TKA). We hypothesize that acute nerve decompression patients will have better long-term outcomes to patients treated non-operatively for peroneal nerve palsies after TKA.
Detailed description
Peroneal nerve palsy after TKA has been reported in the literature to be 0.3% to 1.5%, although it can be as high as 9.5%. Several risk factors have been described: preoperative valgus deformity and flexion contracture, prolonged intraoperative use of a tourniquet, use of epidural anesthesia, and rheumatoid arthritis. Peroneal palsy is rarely diagnosed on postoperative day 0, but in more than 85% of cases, it presents prior to postoperative day 4.Initial treatment should include flexing the knee, removing any compressive bandages, and discontinuing epidural anesthesia. When there are residual deficits, supportive measures are initiated, including application of an ankle-foot orthosis and physical therapy to prevent ankle contracture. If there is no clinical recovery by six to twelve weeks, electromyography (EMG) is typically performed. Some clinicians have advocated the use of EMG studies in the acute phase. In cases of incomplete recovery, delayed surgical exploration and decompression of the peroneal nerve is an option that has been reported to improve outcomes. Unfortunately, not all cases respond, even with surgical treatment. In addition, little information is available describing the outcomes of acute surgical decompression for peroneal nerve palsy after total knee arthroplasty.
While there have been retrospective case reports and series that have examined outcomes after delayed peroneal nerve decompression, we are unaware of reports describing acute decompression. Delayed decompression of the peroneal nerve has been associated with the return of nerve function. Krackow et al. reported the results of five patients who underwent delayed surgical decompression for peroneal nerve palsy after total knee arthroplasty at an average of 27.2 months (range, 5-50 months) and found that 100% were able to discontinue use of the ankle-foot orthosis and 80% had full neurological recovery. The patient who had partial return of neurological function did not undergo decompression until almost four years postoperatively. Mont et al. found that, in patients who underwent surgical peroneal nerve decompression two to sixty months following total knee arthroplasty, 97% reported functional and subjective improvements at a mean of three years post-decompression and were able to discontinue use of the ankle-foot orthosis. Only 33% of the patients who were managed nonoperatively reported improvement in functional and subjective outcomes.
Therefore, in 33% of the patients, an acute decompression would not have been necessary, but in the other 67%, it may have been beneficial. In both studies, patients underwent a trial of nonoperative treatment, and no patient underwent a peroneal nerve decompression earlier than two months after the index total knee arthroplasty. Initial experience with two peroneal nerve palsies following TKA has encouraged some institutions to offer acute decompression to all patients who present with peroneal palsy following total knee arthroplasty. This parallels the practice patterns regarding the wrist, where an acute carpal tunnel release is performed to avoid complications when a patient demonstrates carpal tunnel compressive symptoms postoperatively from wrist surgery. While most patients will improve with nonoperative treatment over time, acute decompression may accelerate recovery, which can decrease uncertainty and stress for both the patient and the surgeon. The surgical technique is relatively straightforward; however, the surgeon and patient must consider the risks of a second anesthetic and operation. In previous experiences with both acute and delayed decompression, while direct damage to the nerve itself is rare, fascial bands, hematomas, and local edema are typically identified that contribute to the compression of the peroneal nerve. Therefore, while nonoperative treatment would possibly result in a return of nerve function once the hematoma resorbed and edema decreased, there may still be some residual dysfunction from the time period of nerve compression and thickened fascial bands around the nerve. Additional study of acute decompression is warranted to understand if it offers both short and long-term advantages over nonoperative treatment.
Treatment Groups: Acute Nerve Decompression - patients will initially receive conservative management (flexing the knee, removing any compressive bandages, and discontinuing epidural anesthesia) followed by a peroneal nerve decompression within 1 week of diagnosis of peroneal nerve palsy. Decompression involves surgical intervention in the setting of a sterile operating room. The patient will be provided with multiple options of anesthesia (per discussion with the anesthesia team). The surgical procedure involves an incision at the lateral aspect of the knee, near the proximal fibula at the level of the fibular neck. The peroneal nerve is carefully identified and dissected. Tissue surrounding or impinging the nerve is carefully removed or cut to rid the compressive environment. The nerve is re- examined to ensure there are no additional points of compression/irritation. The soft-tissues and skin are subsequently closed with suture. Nonoperative Treatment - patients will receive conservative management (flexing the knee, removing any compressive bandages, and discontinuing epidural anesthesia) as well as supportive measures (ankle-foot orthosis and physical therapy) for symptoms lasting longer than 6 week. Outcome Measures: Primary Measure - ≥ 3/5 dorsiflexion strength 3 months after surgery/randomization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative | Experimental | Procedure: Nerve decompressionPeroneal nerve decompression |
| Non-operative | Active comparator | Other: Non-operativePhysical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient presenting with peroneal palsy (< 3/5 dorsiflexion) within 3-weeks after primary TKA
Key exclusion criteria (1 listed)
- Patient's with pre-existing peroneal palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve decompression | Procedure or surgery | Operative |
| Non-operativePhysical therapy | Other | Non-operative |
Primary outcome
Dorsiflexion strength
Time frame: within 3 months from surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Fernandez, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve decompression and Non-operative in people with Peroneal Palsy (Foot Drop), run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dorsiflexion strength (time frame: within 3 months from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.