Clinical trial NCT00408096: Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder
Official title: Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: osteoarthritis
shoulder
resurfacing
prosthesis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-12-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether there is a difference between the result of treatment of shoulder osteoarthritis with two different shoulder prostheses.

Detailed description: In this randomized study, we wish to investigate with the use of clinical and radiological parameters whether there is a difference between the result of treatment of shoulder osteoarthritis with the Copeland resurfacing prosthesis and the Global CAP resurfacing prosthesis.

Clinical parameters with the help of the Constant Shoulder Score (CSS) and Western Ontario Osteoarthritis of the Shoulder Index (WOOS):

1. Pain
2. Activities of Daily Living (ADL)
3. Range of Motion (ROM)
4. Muscle strength

Radiologic parameters:

1. Migration of resurfacing prostheses with use of MB-RSA
2. Bone density around the prosthesis measured with Dual Energy X-ray Absorptiometry (DEXA)
3. Correlation between bone density and prosthesis migration

Eligibility criteria: Inclusion Criteria:

1. Patients with shoulder osteoarthritis with cartilage defect of the caput humeri and not the glenoid cavity
2. Aged 18 years or older and fit
3. Informed, written consent -

Exclusion Criteria:

1. Patients found unsuitable preoperatively for a resurfacing prosthesis
2. Patients aged 85 or older
3. Patients with rheumatoid arthritis
4. Patients who previously had undergone shoulder alloplasty or other major shoulder surgery (more than just diagnostic arthroscopy)
5. Patients unable to avoid NSAID after surgery
6. Patients requiring regular systemic steroid treatment
7. Female patients taking hormone substitution
8. Patients with metabolic bone disease
9. Severe shoulder instability with large rotator cuff defect ( will often necessitate special prosthesis components or even major soft-tissue surgery)
10. Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings) -

Primary outcomes:
measure: Migration of resurfacing prostheses
timeFrame: five years
measure: Bone density around the prosthesis
timeFrame: five years
measure: Pain
timeFrame: five years
measure: Activities of Daily Living (ADL)
timeFrame: five years
Secondary outcomes:
measure: Range of Motion (ROM)
timeFrame: five years
measure: Muscle strength
timeFrame: five years
measure: Correlation between bone density and prosthesis migration
timeFrame: five years
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Orthopaedic Department K, Silkeborg Hospital
city: Viborg
country: Denmark
facility: Regionshospitalet Viborg
Study officials:
affiliation: Orthopaedic Department, Aarhus University Hospital
name: Kjeld Soballe, Professor
role: STUDY_DIRECTOR
References:
citation: Mechlenburg I, Klebe TM, Dossing KV, Amstrup A, Soballe K, Stilling M. Evaluation of periprosthetic bone mineral density and postoperative migration of humeral head resurfacing implants: two-year results of a randomized controlled clinical trial. J Shoulder Elbow Surg. 2014 Oct;23(10):1427-36. doi: 10.1016/j.jse.2014.05.012.