Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder
August 15, 2018 updated by: University of Aarhus
Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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):
- Pain
- Activities of Daily Living (ADL)
- Range of Motion (ROM)
- Muscle strength
Radiologic parameters:
- Migration of resurfacing prostheses with use of MB-RSA
- Bone density around the prosthesis measured with Dual Energy X-ray Absorptiometry (DEXA)
- Correlation between bone density and prosthesis migration
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Silkeborg, Denmark, 8600
- Orthopaedic Department K, Silkeborg Hospital
-
Viborg, Denmark, 8800
- Regionshospitalet Viborg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with shoulder osteoarthritis with cartilage defect of the caput humeri and not the glenoid cavity
- Aged 18 years or older and fit
- Informed, written consent -
Exclusion Criteria:
- Patients found unsuitable preoperatively for a resurfacing prosthesis
- Patients aged 85 or older
- Patients with rheumatoid arthritis
- Patients who previously had undergone shoulder alloplasty or other major shoulder surgery (more than just diagnostic arthroscopy)
- Patients unable to avoid NSAID after surgery
- Patients requiring regular systemic steroid treatment
- Female patients taking hormone substitution
- Patients with metabolic bone disease
- Severe shoulder instability with large rotator cuff defect ( will often necessitate special prosthesis components or even major soft-tissue surgery)
- Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings) -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 1
The Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis
|
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
|
|
ACTIVE_COMPARATOR: 2
The Global Cap uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis
|
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Activities of Daily Living (ADL)
Time Frame: five years
|
five years
|
|
Migration of resurfacing prostheses
Time Frame: five years
|
five years
|
|
Bone density around the prosthesis
Time Frame: five years
|
five years
|
|
Pain
Time Frame: five years
|
five years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Range of Motion (ROM)
Time Frame: five years
|
five years
|
|
Muscle strength
Time Frame: five years
|
five years
|
|
Correlation between bone density and prosthesis migration
Time Frame: five years
|
five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
January 1, 2018
Study Registration Dates
First Submitted
December 5, 2006
First Submitted That Met QC Criteria
December 5, 2006
First Posted (ESTIMATE)
December 6, 2006
Study Record Updates
Last Update Posted (ACTUAL)
August 16, 2018
Last Update Submitted That Met QC Criteria
August 15, 2018
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20060165
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.