NCT02856958

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

August 2, 2016

Last Update Submit

April 9, 2018

Conditions

Peroneal Palsy (Foot Drop)

Outcome Measures

Primary Outcomes (1)

  • Dorsiflexion strength

    within 3 months from surgery

Study Arms (2)

Operative

EXPERIMENTAL

Peroneal nerve decompression

Procedure: Nerve decompression

Non-operative

ACTIVE COMPARATOR

Physical therapy

Other: Non-operative

Interventions

Nerve decompressionPROCEDURE
Operative
Non-operativeOTHER

Physical therapy

Non-operative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient presenting with peroneal palsy (\< 3/5 dorsiflexion) within 3-weeks after primary TKA

You may not qualify if:

  • Patient's with pre-existing peroneal palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwest Orthopedics at Rush

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • John J Fernandez, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 5, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

US(1)