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

This study is currently recruiting participants.
Verified January 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00408096
First received: December 5, 2006
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis
 Procedure: Copeland or Global CAP resurfacing prosthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Migration of resurfacing prostheses [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Bone density around the prosthesis [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Activities of Daily Living (ADL) [ Time Frame: five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Range of Motion (ROM) [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Muscle strength [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Correlation between bone density and prosthesis migration [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2006
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis
 Procedure: Copeland or Global CAP resurfacing prosthesis
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
 Procedure: Copeland or Global CAP resurfacing prosthesis
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408096

Contacts
Contact: Maiken Stilling, MD +45 89 49 74 66 MAIKEN.STILLING@KI.AU.DK
Contact: Inger B Mechlenburg, MSc +45 65371093 INGER.MECHLENBURG@KI.AU.DK

Locations
Denmark
Orthopaedic Department K, Silkeborg Hospital Recruiting
Silkeborg, Denmark, 8600
Contact: Thomas Klebe, MD     +45 87 22 27 66     kotmk@sc.aaa.dk    
Principal Investigator: Maiken Stilling, MD            
Regionshospitalet Viborg Recruiting
Viborg, Denmark, 8800
Contact: Kaj Døssing, MD     +0045 89272753        
Principal Investigator: Maiken Stilling, MD            
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Kjeld Soballe, Professor Orthopaedic Department, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00408096     History of Changes
Other Study ID Numbers: 20060165
Study First Received: December 5, 2006
Last Updated: January 11, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
osteoarthritis
shoulder
resurfacing
prosthesis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013