NCT00408096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2006

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 16, 2018

Status Verified

October 1, 2014

Enrollment Period

9.3 years

First QC Date

December 5, 2006

Last Update Submit

August 15, 2018

Conditions

Osteoarthritis

Keywords

osteoarthritisshoulderresurfacingprosthesis

Outcome Measures

Primary Outcomes (4)

  • Migration of resurfacing prostheses

    five years

  • Bone density around the prosthesis

    five years

  • Pain

    five years

  • Activities of Daily Living (ADL)

    five years

Secondary Outcomes (3)

  • Range of Motion (ROM)

    five years

  • Muscle strength

    five years

  • Correlation between bone density and prosthesis migration

    five years

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

Copeland or Global CAP resurfacing prosthesisPROCEDURE

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

12

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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) -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orthopaedic Department K, Silkeborg Hospital

Silkeborg, 8600, Denmark

Location

Regionshospitalet Viborg

Viborg, 8800, Denmark

Location

Related Publications (2)

  • Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.

    PMID: 36422666DERIVED

  • 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.

    PMID: 25220196DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjeld Soballe, Professor

    Orthopaedic Department, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2006

First Posted

December 6, 2006

Study Start

December 1, 2006

Primary Completion

March 1, 2016

Study Completion

January 1, 2018

Last Updated

August 16, 2018

Record last verified: 2014-10

Locations

DK(2)