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

Osteoarthritis Clinical Trial

Official title:

Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408096
• Other study ID #: 20060165
• Status: Completed
• Phase: N/A
• Start date: December 2006
• Est. completion date: January 2018

Study information

• Verified date: October 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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) -

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Copeland or Global CAP resurfacing prosthesis
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.

Locations

Country	Name	City	State
Denmark	Orthopaedic Department K, Silkeborg Hospital	Silkeborg
Denmark	Regionshospitalet Viborg	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration of resurfacing prostheses		five years
Primary	Bone density around the prosthesis		five years
Primary	Pain		five years
Primary	Activities of Daily Living (ADL)		five years
Secondary	Range of Motion (ROM)		five years
Secondary	Muscle strength		five years
Secondary	Correlation between bone density and prosthesis migration		five years