Clinical trial NCT05450510: Slow and Accelerated Rehabilitation Protocols
Official title: Effects of Slow and Accelerated Rehabilitation Protocols After Latissimus Dorsi Transfer in Massive, Irreparable Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Injuries
Rotator Cuff Tears
Pain, Shoulder
Keywords: Rotator Cuff Injuries
tear
pain
shoulder
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: Latissimus dorsi transfer is an established treatment option with favorable results in massive, irreparable rotator cuff tears, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

Detailed description: A variety of surgical options are proposed in the treatment of massive cuff tears. The treatment options include acromioplasty and tuberoplasty, partial repair with or without soft tissue augmentation, latissimus dorsi transfer (LDT), superior capsular reconstruction (SCR), and reverse total shoulder arthroplasty. Among these options, LDT is a well-recognized technique that aims to rebalance the soft tissue tension around the shoulder joint in order to prevent superior escape of the humeral head and loss of function. From a biomechanical standpoint, the transferred tendon is theorized to function as a humeral head depressor by means of a tenodesis effect, as well as by increasing the active external rotation through the transfer vector. It is an established treatment option with favorable results, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

Eligibility criteria: Inclusion Criteria:

* being in the age range of 18-65 years
* being diagnosed with massive, irreparable rotator cuff tears based on magnetic resonance imaging and clinical continuity tests
* symptoms are unresponsive to conservative care including steroid injections and physiotherapy for at least 6 months
* having a good command of the Turkish language
* scoring above 24 in the Mini Mental State Test
* ≥80% compliance in completing the post-ARCR Phase 1 trainings
* volunteering to participate in the study

Exclusion Criteria:

* diabetes mellitus
* neurological problems
* cervical disc herniation
* visual, verbal, and/or cognitive defects (aphasia, unilateral neglect, etc.)
* systemic inflammatory problems
* hypermobility, trauma, and/or inflammation that could be a contraindication for mobilization
* former shoulder fractures on the affected side
* advanced glenohumeral arthritis (Hamada grade 3),
* deltoid muscle dysfunction,
* irreparable subscapularis tears,
* active infection,
* shoulder stiffness,
* a history of previous shoulder surgery

Primary outcomes:
measure: Visual analog scale
timeFrame: 14 weeks
measure: The Disabilities of the Arm, Shoulder and Hand Questionnaire
timeFrame: 14 weeks
measure: American Shoulder and Elbow Surgeons score
timeFrame: 14 weeks
measure: Western Ontario Rotator Cuff Index
timeFrame: 14 weeks
measure: Constant-Murley Shoulder Score
timeFrame: 14 weeks
Secondary outcomes:
measure: Catastrophizing
timeFrame: 14 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 14 weeks
measure: Tampa-Scale of Kinesiophobia
timeFrame: 14 weeks
measure: 12-Item Short-Form Health Survey
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University
Study officials:
References:
citation: Ozturk BY, Ak S, Gultekin O, Baykus A, Kulduk A. Prospective, randomized evaluation of latissimus dorsi transfer and superior capsular reconstruction in massive, irreparable rotator cuff tears. J Shoulder Elbow Surg. 2021 Jul;30(7):1561-1571. doi: 10.1016/j.jse.2021.01.036. Epub 2021 Mar 4.
citation: Anastasopoulos PP, Alexiadis G, Spyridonos S, Fandridis E. Latissimus Dorsi Transfer in Posterior Irreparable Rotator Cuff Tears. Open Orthop J. 2017 Feb 28;11:77-94. doi: 10.2174/1874325001711010077. eCollection 2017.
citation: Burnier M, Lafosse T. Pectoralis Major and Anterior Latissimus Dorsi Transfer for Subscapularis Tears. Curr Rev Musculoskelet Med. 2020 Dec;13(6):725-733. doi: 10.1007/s12178-020-09674-4.
citation: Elhassan BT, Wagner ER, Kany J. Latissimus dorsi transfer for irreparable subscapularis tear. J Shoulder Elbow Surg. 2020 Oct;29(10):2128-2134. doi: 10.1016/j.jse.2020.02.019. Epub 2020 Jun 9.
citation: Wieser K, Ernstbrunner L, Zumstein MA. Surgical Management of Massive Irreparable Cuff Tears: Latissimus Dorsi Transfer for Posterosuperior Tears. Curr Rev Musculoskelet Med. 2020 Oct;13(5):605-611. doi: 10.1007/s12178-020-09659-3.
citation: Galasso O, Mantovani M, Muraccini M, Berardi A, De Benedetto M, Orlando N, Gasparini G, Castricini R. The latissimus dorsi tendon functions as an external rotator after arthroscopic-assisted transfer for massive irreparable posterosuperior rotator cuff tears. Knee Surg Sports Traumatol Arthrosc. 2020 Jul;28(7):2367-2376. doi: 10.1007/s00167-019-05819-2. Epub 2019 Dec 6.