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CompletedNCT00408096Updated Aug 16, 2018

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

An interventional study of Copeland or Global CAP resurfacing prosthesis in Osteoarthritis, sponsored by University of Aarhus. Completed at 2 sites in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-08-16.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Osteoarthritis

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Keywords

  • osteoarthritis
  • shoulder
  • resurfacing
  • prosthesis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 32 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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) -
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
32 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureCopeland or Global CAP resurfacing prosthesis

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

06

What researchers measure

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

07

Study locations

2 sites
  • Orthopaedic Department K, Silkeborg Hospital
    Silkeborg, 8600, Denmark
  • Regionshospitalet Viborg
    Viborg, 8800, Denmark
08

References and documents

Publications

  • Mechlenburg I, Klebe TM, Dossing KV, Amstrup A, Soballe K, Stilling M. Evaluation of periprosthetic bone mineral density and postoperative migration of humeral head resurfacing implants: two-year results of a randomized controlled clinical trial. J Shoulder Elbow Surg. 2014 Oct;23(10):1427-36. doi: 10.1016/j.jse.2014.05.012. PubMed 25220196 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00408096
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Dec 6, 2006
Start date
Dec 2006
Primary completion
Mar 2016
Completion
Jan 2018
Last update
Aug 16, 2018

Study contacts

Kjeld Soballe, Professor
study director · Orthopaedic Department, Aarhus University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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