OsteoarthritisNCT00408096
Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder
A study testing Copeland or Global CAP resurfacing prosthesis in people with Osteoarthritis, run by University of Aarhus at 2 sites in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Copeland or Global CAP resurfacing prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesDenmark
- Study dates
- Dec 2006to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Show all 10Show fewer
- 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) -
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Orthopaedic Department K, Silkeborg Hospital
Silkeborg, 8600
Regionshospitalet Viborg
Viborg, 8800
About this study
Official title: Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study
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):
- 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
- Conditions
- Osteoarthritis
- Being tested
- Copeland or Global CAP resurfacing prosthesis
- Keywords
- osteoarthritis, shoulder, resurfacing, prosthesis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copeland or Global CAP resurfacing prosthesisProcedure or surgery
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis Receives: 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 Receives: Procedure: Copeland or Global CAP resurfacing prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration of resurfacing prostheses
Measured: five years
Bone density around the prosthesis
Measured: five years
Pain
Measured: five years
Activities of Daily Living (ADL)
Measured: five years
Secondary outcomes (3)
Range of Motion (ROM)
Measured: five years
Muscle strength
Measured: five years
Correlation between bone density and prosthesis migration
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjeld Soballe, Professor, Study director, Orthopaedic Department, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408096
- Sponsor's protocol ID
- 20060165
- Status last verified
- Oct 2014
- First submitted
- 5 Dec 2006
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36422666Mechlenburg 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study
- ClinicalTrials.gov ID
- NCT00408096
- Acronym / sponsor ID
- 20060165
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, shoulder, resurfacing, prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Copeland or Global CAP resurfacing prosthesisThe Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis |
| 2 | Active comparator | Procedure: Copeland or Global CAP resurfacing prosthesisThe Global Cap uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copeland or Global CAP resurfacing prosthesisBoth Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces. | Procedure or surgery | 1, 2 |
Primary outcome
Migration of resurfacing prostheses
Time frame: five years
Bone density around the prosthesis
Time frame: five years
Pain
Time frame: five years
Activities of Daily Living (ADL)
Time frame: five years
3 secondary outcomes
Range of Motion (ROM)
Time frame: five years
Muscle strength
Time frame: five years
Correlation between bone density and prosthesis migration
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Derived from this study: PubMed 36422666Jorgensen 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.
- Derived from this study: PubMed 25220196Mechlenburg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjeld Soballe, Professor study director
Orthopaedic Department, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copeland or Global CAP resurfacing prosthesis in people with Osteoarthritis, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration of resurfacing prostheses (time frame: five years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00408096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.