Arthroscopic Treatment With Ulnar Nerve Release for Elbow Osteoarthritis

Not Applicable

Not yet recruiting

• Conditions: Ulnar Nerve Release; Primary Osteoarthritis, Elbow
• Interventions: Device: without ulnar nerve mini open release; Device: ulnar nerve mini open release

• Registration Number: NCT05184010
• Lead Sponsor: Beijing Jishuitan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-05
• Last Update Submitted: 2022-01-05
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Study Start: 2022-01-30
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Age >18 years
2. Primary osteoarthritis of the elbow with stiffness. Osteoarthritis was confirmed on CT-arthrography, by cartilage damage, osteophytes or local or global joint impingement.
3. Ulnar neuropathy proven by electromyography without clinical symptoms
4. Failure at least 6 months of conservative treatment
5. Availability of medical information for >2 years of follow-up

Exclusion Criteria

1. Severe skin contracture or wound problem that could affect the neurovascular structures or require flap surgery.
2. Revision surgery
3. Ulnar nerve pathology results in clinical symptom such as motion and feeling deficiency
4. Other indication for elbow arthroscopy: synovial or inflammatory rheumatoid pathology, osteochondritis dissecan, acute infection, tumor or pure capsular stiffness.
5. Inadequate or loss of follow-up
6. elbow instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arthroscopic release alone without ulnar nerve mini open release	without ulnar nerve mini open release	-
arthroscopic release with ulnar nerve mini open release	ulnar nerve mini open release	-

Primary Outcome Measures

Name	Time	Method
DASH	baseline-2 years postoperatively	A score used to evaluated the elbow function,range of 0-100, 100 means worst outcome

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Jishuitan hospital; 🇨🇳 Beijing, Beijing, China