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Arthroscopic Treatment With Ulnar Nerve Release for Elbow Osteoarthritis

Primary Purpose

Primary Osteoarthritis, Elbow, Ulnar Nerve Release

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ulnar nerve mini open release
without ulnar nerve mini open release
Sponsored by
Beijing Jishuitan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Osteoarthritis, Elbow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Jishuitan hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

arthroscopic release with ulnar nerve mini open release

arthroscopic release alone without ulnar nerve mini open release

Arm Description

Outcomes

Primary Outcome Measures

DASH
A score used to evaluated the elbow function,range of 0-100, 100 means worst outcome

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2021
Last Updated
January 5, 2022
Sponsor
Beijing Jishuitan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05184010
Brief Title
Arthroscopic Treatment With Ulnar Nerve Release for Elbow Osteoarthritis
Official Title
Arthroscopic Treatment With and Without Ulnar Nerve Release for Elbow Osteoarthritis --a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 30, 2022 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Jishuitan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Osteoarthritis, Elbow, Ulnar Nerve Release

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
arthroscopic release with ulnar nerve mini open release
Arm Type
Experimental
Arm Title
arthroscopic release alone without ulnar nerve mini open release
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
ulnar nerve mini open release
Intervention Description
the ulnar nerve mini open release was performed before arthroscopic release for elbow
Intervention Type
Device
Intervention Name(s)
without ulnar nerve mini open release
Intervention Description
arthroscopic release for elbow stiffness alone without ulnar nerve mini open release
Primary Outcome Measure Information:
Title
DASH
Description
A score used to evaluated the elbow function,range of 0-100, 100 means worst outcome
Time Frame
baseline-2 years postoperatively
Secondary Outcome Measure Information:
Title
ROM(F-E and rotation)
Description
the motion of the elbow
Time Frame
baseline-2 years postoperatively
Title
Strength
Description
the strength test contain flex and extend the elbow, made a comparison with contralateral elbow.
Time Frame
baseline-2 years postoperatively
Title
MEPS
Description
A score used to evaluated the elbow function
Time Frame
baseline-2 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shangzhe Li, M.D.
Phone
+86 13826162999
Email
562744381@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Lu
Organizational Affiliation
Sports Medicine Service, Beijing Jishuitan hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Jishuitan hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Arthroscopic Treatment With Ulnar Nerve Release for Elbow Osteoarthritis

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