The primary aim of the study is the prospective recording and follow-up of the clinical and radiographic data of patients who received soft tissue interpositional arthroplasty with Graft Jacket® as a treatment of painful glenohumeral osteoarthritis…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
NONE
Background summary
When conservative treatment (analgesics, NSAIDs, corticoid injections,
hyaluronic acid injections, physiotherapy,..) fails to control pain in
glenohumeral osteoarthritis, surgical treatment remains the only option.
However, especially in young and active patients, the surgical treatment of
shoulder osteoarthritis is difficult and not always successful. Debridement,
microfracturing, washout with cartilage digestive enzymes, shoulder prosthetic
resurfacing, hemi- or total arthroplasty or arthrodesis have yielded variable
outcomes and complications.
Based upon the promising preliminary results of soft-tissue interposition
arthroplasty with an acellular allograft skin-derived collagen matrix
(GraftJacket®, Wright Medical Technology, Inc. Arlington, TN, USA) in two
groups of patients (first group of 11 young and active patients 1 (mean age: 50
years, range 34-68) * second group of 12 older patients with painful
osteoarthritis and a reasonably good shoulder function), it was decided to set
up an randomized, prospective, controlled follow-up study to assess the
short-term, medium-term and long-term clinical and radiographic outcomes of
this technique compared to arthroscopic glenohumeral joint debridement.
Study objective
The primary aim of the study is the prospective recording and follow-up of the
clinical and radiographic data of patients who received soft tissue
interpositional arthroplasty with Graft Jacket® as a treatment of painful
glenohumeral osteoarthritis in a randomised controlled study set-up comparing
the outcomes with those of arthroscopic debridement.
A secondary scope of the study is to confirm the safety of the use of this
acellular allograft skin-derived collagen matrix (GraftJacket®) as soft-tissue
interpositional device in the shoulder, already demonstrated by the absence of
device-related complications in other series .
Study design
Design and monitoring: The GRAFTJACKET® study is a single centre, randomized,
controlled, prospective, consecutive follow-up study recording the clinical and
radiographic data of the soft-tissue interposition arthroplasty with
GRAFTJACKET® compared to shoulder joint debridement at specific time intervals.
The data will be collected using the Wright Up shoulder software.
Participating centres:
Chief investigator: Dr Pol Huijsmans, HAGA Hospital, Den Haag, the Netherlands
Study burden and risks
NONE
Bosstraat 19
B-9830 Sint-Martens-Latem
BE
Bosstraat 19
B-9830 Sint-Martens-Latem
BE
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15474.098.06 |