Hsiao-Li
Taipei, 11217, Taiwan
NCT Number: NCT03609164
There are several associated structural changes when dealing with massive rotator cuff repair, which include tendon retraction and fragility, muscle atrophy and fatty infiltration, as well as osteoporosis over the tendon insertion. Those changes may lead to difficult in applying double-row repair, suture cutting through the tendon, too much tension over the repair and loosening or pull-out of anchors, which may results in poor tendon-bone healing and subsequent high re-tear rate. Therefore decreasing the tension over the repair site may increase the healing over tendon bone junction as well as decrease the risk of anchors loosening. A suture-spanning augmentation with two set of suture loops passing over musculotendinous junction medially and fixed with anchor at the lateral cortical wall may solve the problem. In order to define the clinical benefit of this adjuvant procedure, a prospective randomized control study is designed to compare the adjunctive reinforce suture with the single-row simple suture repair in massive rotator cuff tear.
Around sixty patients were randomized divided into two groups. The study group was used adjunctive reinforce suture repair technique, which was one lateral cortical anchor holding 2 separated set of transverse looping sutures over the medial musculotendinous junction in addition to single row repair, while the control group was used single row repair technique in simple stitch fashion. All patients will have clinical evaluation in pain (VAS score) and functional recovery (ASES and UCLA score) as well as MRI image for the tendon integrity.
If the suture-spanning augmentation of single-row repair can yield an improved healing rate and fewer complications, massive rotator cuff tear should be repaired earlier in order to prevent the late development of irreparable tear.
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Notify Me40 year–85 year
All sexes
Interventional
Not applicable
Taipei, 11217, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
Using MR imaging to determine the presence or absence of rotator cuff retears
Time frame: 2 years
Record the VAS (pain level from 0-10) by the questionnaire, pre-op/post-op 2-year
Time frame: 2 years
Record the ASES score by the questionnaire, focus on joint pain, instability, and activities of daily living, pre-op/post-op 2year
Time frame: 2 years
Record the UCLA shoulder score by the questionnaire, focusing on five sub-scales made up of: active forward elevation and strength (physician reported), pain, satisfaction, and function (patient reported), pre-op/post-op 2-year
Time frame: 2 years
Record the shoulder constant score by the questionnaire, focusing on ROM, functional assessment, strength measure, pre-op/post-op 2-year
Taipei Veterans General Hospital, Taiwan
Other Gov
Does the Arthroscopic Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?
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