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Een gerandomiseerde studie tussen twee typen peesomleggingen als behandeling voor zeer grote scheuren in de schouderpezen


- candidate number19254
- NTR NumberNTR4721
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2014
- Secondary IDsP11.183 METC LUMC 37838 CCMO
- Public TitleEen gerandomiseerde studie tussen twee typen peesomleggingen als behandeling voor zeer grote scheuren in de schouderpezen
- Scientific TitleTeres Major versus Latissimus Dorsi tendon transfer in posterosuperior RC Tears: a randomised controlled trial
- ACRONYMTesla
- hypothesisTeres Major muscle transfer group will show significant better improvement in active abduction and external rotation than the LD group after 1 year.
- Healt Condition(s) or Problem(s) studiedShoulder disorders , Complaints of shoulder, Rotator cuff
- Inclusion criteria1) Patients suffering MRI proven massive RC tears. A massive Rotator Cuff tear is defined as a type III tear according to Davidson et al. Retraction grade II or III acoording to Patte and Grade >II fatty infiltration.
2) Invalidating pain of the affected shoulder
3) Functional deficit (loss of external rotation and/or abduction)
- Exclusion criteria-Tear of the m. subscapularis
-Radiographic osteoarthritis of the glenohumeral joint of Kellgren > grade 2 and/or acromioclavicular joint and/or sternoclavicular joint - History of fractures or dislocation of the shoulder
- Tumors
- No informed consent
- Insufficient Dutch Language skills
- Age <18 years and >80
- Contra-indications for surgery
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2012
- planned closingdate1-sep-2019
- Target number of participants40
- InterventionsTeres major muscle transfer versus latissimus dorsi muscle transfer

The patient is positioned in lateral position on the unaffected side. The first skin incision runs just above the posterior pillar of the armpit. The muscle of interest is identified, transversing under the medial head or the triceps. dorsi. The axillary and radial nerves are identified above and below the tendon insertion.
The tendon is detached from the humerus. The second skin incision is made lateral from the acromion process (deltoid split approach). The deltoid is split and the subdeltoid bursaopened. The rotator cuff is examined. The tendon is passed under the posterior part of the deltoid muscle to the subacromial space. The tendon is inserted in the m. infraspinatus area using one or two bone-anchors.
- Primary outcomeConstant score at 1 year postoperatively
- Secondary outcomeConstant score at 3 and 6 months postoperatively.

At 3,6 and 12 months postoperatively.
Range of motion using a goniometer and an electromagnetic tracking device.
EMG activity of various shoulder muscles.
Visual analogue scale for pain.
Complications
Re-operations or other interventions.
SF-12
DASH
WORC
- Timepoints3-6 and 12 months postoperatively
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. R.G.H.H. Nelissen
- CONTACT for SCIENTIFIC QUERIESDr. R.G.H.H. Nelissen
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-aug-2014 - 2-sep-2014


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