Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Copeland or Global CAP resurfacing prosthesis

• Registration Number: NCT00408096
• Lead Sponsor: University of Aarhus

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

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-05
• Study First Submitted QC: 2006-12-05
• Study First Posted: 2006-12-06
• Status Verified: 2014-10
• Primary Completion: 2016-03
• Study Completion: 2018-01
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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) -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Copeland or Global CAP resurfacing prosthesis	The Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis
2	Copeland or Global CAP resurfacing prosthesis	The Global Cap uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis

Primary Outcome Measures

Name	Time	Method
Migration of resurfacing prostheses	five years
Bone density around the prosthesis	five years
Activities of Daily Living (ADL)	five years
Pain	five years

Secondary Outcome Measures

Name	Time	Method
Correlation between bone density and prosthesis migration	five years
Range of Motion (ROM)	five years
Muscle strength	five years

Trial Locations

Locations (2)

Orthopaedic Department K, Silkeborg Hospital; 🇩🇰 Silkeborg, Denmark

Regionshospitalet Viborg; 🇩🇰 Viborg, Denmark