Acute Nerve Decompression Versus Non-operative Treatment for Peroneal Nerve Palsy Following Primary Total Knee Arthroplasty
Primary Purpose
Peroneal Palsy (Foot Drop)
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nerve decompression
Non-operative
Sponsored by
About this trial
This is an interventional treatment trial for Peroneal Palsy (Foot Drop)
Eligibility Criteria
Inclusion Criteria:
- Any patient presenting with peroneal palsy (< 3/5 dorsiflexion) within 3-weeks after primary TKA
Exclusion Criteria:
- Patient's with pre-existing peroneal palsy
Sites / Locations
- Midwest Orthopedics at Rush
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Operative
Non-operative
Arm Description
Peroneal nerve decompression
Physical therapy
Outcomes
Primary Outcome Measures
Dorsiflexion strength
Secondary Outcome Measures
Full Information
NCT ID
NCT02856958
First Posted
August 2, 2016
Last Updated
April 9, 2018
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02856958
Brief Title
Acute Nerve Decompression Versus Non-operative Treatment for Peroneal Nerve Palsy Following Primary Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peroneal Palsy (Foot Drop)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Operative
Arm Type
Experimental
Arm Description
Peroneal nerve decompression
Arm Title
Non-operative
Arm Type
Active Comparator
Arm Description
Physical therapy
Intervention Type
Procedure
Intervention Name(s)
Nerve decompression
Intervention Type
Other
Intervention Name(s)
Non-operative
Intervention Description
Physical therapy
Primary Outcome Measure Information:
Title
Dorsiflexion strength
Time Frame
within 3 months from surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient presenting with peroneal palsy (< 3/5 dorsiflexion) within 3-weeks after primary TKA
Exclusion Criteria:
Patient's with pre-existing peroneal palsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Fernandez, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midwest Orthopedics at Rush
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acute Nerve Decompression Versus Non-operative Treatment for Peroneal Nerve Palsy Following Primary Total Knee Arthroplasty
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