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Cutting the long biceps tendon as a treatment for elderly patients with a shoulder tendon rupture.


- candidate number22465
- NTR NumberNTR5700
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2015
- Secondary IDs15.08131 METC Zwolle
- Public TitleCutting the long biceps tendon as a treatment for elderly patients with a shoulder tendon rupture.
- Scientific TitleTenotomy of the long head of the biceps tendon as treatment for elderly patients with degenerative rotator cuff rupture.
- ACRONYMBITE-study
- hypothesis
- Healt Condition(s) or Problem(s) studiedRotator cuff, Bicepstendon
- Inclusion criteria1. Age 65 years or more
2. Clinical suspection rotator cuff rupture with pain and/or weakness of the supraspinatus tendon or infraspinatus tendon
3. MRI of the affected shoulder, by two reviewers assessed as full thickness supra- and/or infraspinatus tendon rupture with intact and non-dislocated long head of the biceps tendon.
4. Signed informed consent.
- Exclusion criteria1. Frozen shoulder (in more than three directions less than 50% of the normal range of motion when passive physical examination is done).
2. Symptomatic AC-arthrosis ipsilateral side.
3. (Reumatoid) arthritis.
4. Diabetes Mellitus (type 1 and 2).
5. Language barrier/ cognitive problems (not capable to fill in questionnaires).
6. Neurologic problems with functional shoulder complaints.
7. Surgery in the past in the concerning shoulder.
8. Glenohumoral osteoarthritis.
9. Inclusion of the other shoulder in this study.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blinding[default]
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytype[default]
- planned startdate 1-nov-2015
- planned closingdate
- Target number of participants120
- InterventionsMulticenter randomised controlled study in which patients are recruited for one year. There will be three treatment groups in which patients can be randomised: arthroscopic tenotomy long head biceps tendon vs. arthroscopic debridement vs. conservative treatment (physical therapy). The study will be conducted at the orthopedic department of the Deventer Hospital, Martini Hospital Groningen, Leeuwarden Medical Centre and Orthopaedic Center East Netherlands (Hengelo / Almelo).
- Primary outcomeConstant-Murley Score (CMS)
- Secondary outcomeOxford Shoulder Score (OSS)
- TimepointsT0=baseline
T1=6 weeks
T2=3 months
T3=6 months
T4=12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES A.V. Boeddha
- CONTACT for SCIENTIFIC QUERIES A.V. Boeddha
- Sponsor/Initiator Deventer Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Deventer Ziekenhuis
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD15-jul-2015 - 16-apr-2016


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