Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder - Full Text View

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

MedlinePlus related topics:

Osteoarthritis

Drug Information available for:

Durapatite

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Efficacy Study

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

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 2013
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator The Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area.	Procedure: Copeland or Global CAP resurfacing prosthesis Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
2: Active Comparator The Global Cap uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area.	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):

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

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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) -

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

Sponsors and Collaborators

University of Aarhus

Investigators


Study Director:	Kjeld Soballe, Professor	Orthopaedic Department, Aarhus University Hospital

More Information

Responsible Party:	Aarhus University Hospital ( Maiken Stilling, MD )
Study ID Numbers:	20060165
First Received:	December 5, 2006
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00408096
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

osteoarthritis

shoulder

resurfacing

prosthesis

Study placed in the following topic categories:

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00408096