Arthroscopic Treatment With Ulnar Nerve Release for Elbow Osteoarthritis

NCT ID: NCT05184010

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-30

Study Completion Date

2024-12-30

Brief Summary

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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

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Conditions

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Primary Osteoarthritis, Elbow Ulnar Nerve Release

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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arthroscopic release with ulnar nerve mini open release

Group Type EXPERIMENTAL

ulnar nerve mini open release

Intervention Type DEVICE

the ulnar nerve mini open release was performed before arthroscopic release for elbow

arthroscopic release alone without ulnar nerve mini open release

Group Type PLACEBO_COMPARATOR

without ulnar nerve mini open release

Intervention Type DEVICE

arthroscopic release for elbow stiffness alone without ulnar nerve mini open release

Interventions

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ulnar nerve mini open release

the ulnar nerve mini open release was performed before arthroscopic release for elbow

Intervention Type DEVICE

without ulnar nerve mini open release

arthroscopic release for elbow stiffness alone without ulnar nerve mini open release

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi Lu

Director of Sports Medicine Service of Beijing Jishuitan hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Lu

Role: PRINCIPAL_INVESTIGATOR

Sports Medicine Service, Beijing Jishuitan hospital

Locations

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Beijing Jishuitan hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Shangzhe Li, M.D.

Role: CONTACT

+86 13826162999

Other Identifiers

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Yi Lu

Identifier Type: -

Identifier Source: org_study_id

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