Arthroscopic Treatment With Ulnar Nerve Release for Elbow Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study is a prospective randomized controlled study of arthroscopic release for primary osteoarthritis of the elbow with stiffness with or without ulnar nerve release. The patients with primary osteoarthritis of the elbow with stiffness, which ulnar neuropathy proven by electromyography without clinical symptoms, were randomly divided into groups before the operation. Before the arthroscopic operation was began, the procedure of ulnar nerve release was performed according to the group(release group or unrelease group). In different time periods postoperatively, the quantitative and qualitative indicators including pain, functional score, muscle strength, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with ulnar nerve release.

Official Title
-----------------
Arthroscopic Treatment With and Without Ulnar Nerve Release for Elbow Osteoarthritis --a Prospective Randomized Controlled Trial

Conditions
-----------------
Primary Osteoarthritis, Elbow, Ulnar Nerve Release

Intervention / Treatment
-----------------
* Device: ulnar nerve mini open release
* Device: without ulnar nerve mini open release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Primary osteoarthritis of the elbow with stiffness. Osteoarthritis was confirmed on CT-arthrography, by cartilage damage, osteophytes or local or global joint impingement. Ulnar neuropathy proven by electromyography without clinical symptoms Failure at least 6 months of conservative treatment Availability of medical information for >2 years of follow-up Exclusion Criteria: Severe skin contracture or wound problem that could affect the neurovascular structures or require flap surgery. Revision surgery Ulnar nerve pathology results in clinical symptom such as motion and feeling deficiency Other indication for elbow arthroscopy: synovial or inflammatory rheumatoid pathology, osteochondritis dissecan, acute infection, tumor or pure capsular stiffness. Inadequate or loss of follow-up elbow instability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arthroscopic release with ulnar nerve mini open release<br> | Device: ulnar nerve mini open release<br>* the ulnar nerve mini open release was performed before arthroscopic release for elbow<br>|
| Placebo Comparator: arthroscopic release alone without ulnar nerve mini open release<br> | Device: without ulnar nerve mini open release<br>* arthroscopic release for elbow stiffness alone without ulnar nerve mini open release<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH | A score used to evaluated the elbow function,range of 0-100, 100 means worst outcome | baseline-2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROM(F-E and rotation) | the motion of the elbow | baseline-2 years postoperatively | 
| Strength | the strength test contain flex and extend the elbow, made a comparison with contralateral elbow. | baseline-2 years postoperatively | 
| MEPS | A score used to evaluated the elbow function | baseline-2 years postoperatively |