The study is primarily designed to compare the clinical outcome between the TM transfer and the LD transfer in patients with a massive posterosuperior rotator cuff tear. Our secondary objective is to asses the quality of life in patients undergoing…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the Constant Score (CS), pre-operative and 1 year
postoperative.
Secondary outcome
Secondary parameters are RoM, EMG, SF-12, DASH and WORC.
Background summary
Various types of muscle tendon transfers have been proposed as a salvage
procedure for irreparable posterosuperior massive rotator cuff (RC) tears, of
which 2 have been more widely adopted: the m. teres major (TM) transfer and m.
latissimus dorsi (LD) transfer. In an analysis of muscle function (EMG), the TM
proved to be successful. Yet no long-term clinical outcome results has been
reported for the TM transfer. Midterm and long turn outcome of LD transfer are
relatively favourable, however reported only in small research patient
populations. Our hypothesis is that at short term follow-up (3 months, 6
months) the clinical results with be comparable in both groups. After 1 year
and 2 year of follow-up the clinical outcome, expressed in Constant Score (CS)
and Range of Motion (RoM), will be increased in both patient groups versus the
pre-operative figures, yet it is suspected that the TM transfer will lead to a
significant greater increase in external rotation in adduction and abduction
and thereby in clinical outcome, as compared to the LD transfer group.
Study objective
The study is primarily designed to compare the clinical outcome between the TM
transfer and the LD transfer in patients with a massive posterosuperior rotator
cuff tear. Our secondary objective is to asses the quality of life in patients
undergoing either a TM transfer or a LD transfer.
Study design
Randomized controlled clinical trial, double-blinded for observer with two
groups, one will receive a TM transfer and the other group will receive a LD
transfer.
Intervention
Tendon transfer
Study burden and risks
Because all interventions we will apply are standard treatment of patients with
symptomatic massive rotator cuff tear, risks and possible burdens are the same
as compared to the standard clinical situation. The questionnaires,
biomechanical measurements will cost extra time for the patient. Preoperative,
investigations at the laboratory can take up to 50 minutes, including patient
history, full RoM, CS, EMG and three self report questionnaires (SF-12, DASH
and WORC). At 3 months and 6 months postoperative, patients will receive a full
RoM evaluation, CS and the questionnaires will be administered. This will take
up to 30 minutes per appointment. One year and two year postoperative,
investigations at the laboratory include patient history, full RoM, CS, EMG and
three self report questionnaires (SF-12, DASH and WORC). No physiological
discomfort during test administration is to be expected. Appointments are
scheduled the same day as the appointments made at the outpatient clinic for
usual healthcare follow-up.
Next to the RCT related variables, muscle biopsies are obtained from de
deltoid, infraspinatus and teres major muscle.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Retraction and fatty infiltration of the m. supraspinatus and m. infraspinatus (irreparable posterosuperior RC tear) on MRI
- Invalidating pain of the affected shoulder
- 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
<18 years and >80
Contra-indication for surgery
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37838.058.11 |