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

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ClinicalTrials.gov Identifier: NCT00408096
Recruitment Status : Unknown
Verified October 2014 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : December 6, 2006
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoarthritis Procedure: Copeland or Global CAP resurfacing prosthesis

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : December 2006
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
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.



Primary Outcome Measures :
  1. Migration of resurfacing prostheses [ Time Frame: five years ]
  2. Bone density around the prosthesis [ Time Frame: five years ]
  3. Pain [ Time Frame: five years ]
  4. Activities of Daily Living (ADL) [ Time Frame: five years ]

Secondary Outcome Measures :
  1. Range of Motion (ROM) [ Time Frame: five years ]
  2. Muscle strength [ Time Frame: five years ]
  3. Correlation between bone density and prosthesis migration [ Time Frame: five years ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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) -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408096


Locations
Denmark
Orthopaedic Department K, Silkeborg Hospital
Silkeborg, Denmark, 8600
Regionshospitalet Viborg
Viborg, Denmark, 8800
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Kjeld Soballe, Professor Orthopaedic Department, Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00408096     History of Changes
Other Study ID Numbers: 20060165
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014

Keywords provided by University of Aarhus:
osteoarthritis
shoulder
resurfacing
prosthesis

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