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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in United States

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

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 groups in NCT02856958
Study groupRoleWhat they receive
OperativeExperimentalPeroneal nerve decompression
Receives: Procedure: Nerve decompression
Non-operativeActive comparatorPhysical therapy
Receives: Other: Non-operative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted5 Aug 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJul 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Why it stopped: No participants enrolled

Resources

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)
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

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.

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