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

Randomised controlled clinical trial with GRAFTJACKET® , arthroscopic, soft-tissue interposition arthroplasty as a treatment of glenohumeral osteoarthritis. - GJ200609RCDH

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30503
Enrollment
20
Registered
2007-03-23
Start date
2007-05-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glenoid arthrosis osteoarthritis

Interventions

None listed

Sponsors

onafhankelijk consultant clinical research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Pain (VAS) en shoulder function (via Constant score, Oxford shoulder score, Womac, UCLA activity score) General physical and mental health (via SF-12) Radiographic evaluation of the osteoarthritis MRI evaluation of the articular surfaces

Secondary

MeasureTime frame
NONE

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)