Conform and non conform glenoid components in total shoulder replacements
| ISRCTN | ISRCTN42881741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42881741 |
| Secondary identifying numbers | p06.017 |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 28/12/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F Steenbrink
Scientific
Scientific
Leiden University Medical Center
Departement of Orthopaedics
Laboratory for Movement Analysis
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31(0)71 526 2581 |
|---|---|
| f.steenbrink@lumc.nl |
Study information
| Study design | Randomised, controlled, parallel group, double blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Conform components are beneficial for motion coordination and reducing high rim-loads, while non-conform components are beneficial in reducing high humerus-to-scapula impulses (impact forces). |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Shoulder disorders |
| Intervention | Total shoulder replacement |
| Intervention type | Other |
| Primary outcome measure | 1. Component fixation (Rontgen Stereophotographic Analysis [RSA]) 2. Shoulder functioning (Range of Motion [RoM], Questionnaires for shoulder functioning) |
| Secondary outcome measures | 1. Glenohumeral translation (Fluoroscopy) 2. Pain (Visual Analogue Scale [VAS]) 3. Maximum arm force 4. Shoulder coordination (Principal action) 5. Proprosepsis (mirroring) |
| Overall study start date | 01/11/2006 |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | Individuals requiring primary arthroplasty as a result of osteoarthritis or rheumatoid arthritis. |
| Key exclusion criteria | 1. Rotator cuff tear, pre-operatively diagnosed by means of Magnetic Resonance Imaging (MRI) 2. Humeral component with a radius of 20 mm 3. Prior history of shoulder surgery |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Center (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Orthopaedics
Laboratory for Movement Analysis
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html |
|---|---|
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Industry
Reumafonds (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
