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Completed

NCT Number: NCT00408096

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Department K, Silkeborg Hospital, Silkeborg, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) -

Treatment and study plan

Copeland or Global CAP resurfacing prosthesis

Procedure

Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2016
Study completion
2018
First posted
Dec 6, 2006
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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