Arthroscopic Treatment With Ulnar Nerve Release for Elbow Osteoarthritis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Osteoarthritis, Elbow; Ulnar Nerve Release
• Intervention / Treatment: Device: ulnar nerve mini open release; Device: without ulnar nerve mini open release

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Jishuitan hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: arthroscopic release with ulnar nerve mini open release	Device: ulnar nerve mini open release; the ulnar nerve mini open release was performed before arthroscopic release for elbow
PLACEBO_COMPARATOR: arthroscopic release alone without ulnar nerve mini open release	Device: without ulnar nerve mini open release; arthroscopic release for elbow stiffness alone without ulnar nerve mini open release

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

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 30, 2022
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (ACTUAL): January 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Yi Lu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No