Randomised controlled clinical trial with GRAFTJACKET® , arthroscopic, soft-tissue interposition arthroplasty as a treatment of glenohumeral osteoarthritis.

Completed

• Conditions: glenoid arthrosis; osteoarthritis; 10028377

• Registration Number: NL-OMON30503
• Lead Sponsor: onafhankelijk consultant clinical research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Painful, non-inflammatory osteoarthritis (OA) of the shoulder
2. Pre-operative radiographic confirmation of osteoarthritis of the shoulder (Kellgren-Lawrence Numerical Grading system Grade 2-4) and/or confirmation of glenoid osteoarthritis at the time of arthroscopy.
3. Patient has pain from shoulder OA not responsive to conservative treatment (NSAIDS, Analgesics, physical therapy, hyaluronic acid or corticosteroid injections): if the patient has been treated conservatively elsewhere during at least 3 months and without success, he (she) may immediately be included into the study. If the patient has not received any conservative treatment at the time of the first visit, the investigator will treat the patient with conservative measures first during three months and only include him (her) into the study in the case of persistent pain.
4. Patient is at least 18 years of age and skeletally mature.
5. Patient is otherwise in good health
6. Patient is expected to recover completely
7. Patient is willing and able to come to follow-up examinations
8. Patient has signed an informed consent

Exclusion Criteria

1. Presence of primary inflammatory arthropathy (rheumatoid, psoriatic or gouty arthritis)
2. Rapidly progressive chondrolysis of the humeral head.
3. Avascular necrosis of the humeral head
4. Infection of the shoulder joint or subacromial space.
5. Severe Rotator Cuff pathology.
6. Patient is younger than 18 years old or skeletally immature
7. Patient has a short life expectancy.
8. Patient is not willing and/or able to come to follow-up examinations
9. Patient has not signed the informed consent to record and collect his health information

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain (VAS) en shoulder function (via Constant score, Oxford shoulder score,<br /><br>Womac, UCLA activity score)<br /><br>General physical and mental health (via SF-12)<br /><br>Radiographic evaluation of the osteoarthritis<br /><br>MRI evaluation of the articular surfaces</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NONE</p><br>