Slow and Accelerated Rehabilitation Protocols

Official title

Effects of Slow and Accelerated Rehabilitation Protocols After Latissimus Dorsi Transfer in Massive, Irreparable Rotator Cuff Tears

Overview

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.

Interventions

• Other Accelerated (ACCEL) protocol group
  After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 8-week-long Phase 2 and Phase 3 trainings.
• Other Slow (SLOW) protocol group
  After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 14-week-long Phase 2 and Phase 3 trainings.

Primary outcome measures

• Visual analog scale [Time frame: 14 weeks]
• The Disabilities of the Arm, Shoulder and Hand Questionnaire [Time frame: 14 weeks]
• American Shoulder and Elbow Surgeons score [Time frame: 14 weeks]
• Western Ontario Rotator Cuff Index [Time frame: 14 weeks]
• Constant-Murley Shoulder Score [Time frame: 14 weeks]

Secondary outcome measures (4)

• Catastrophizing [Time frame: 14 weeks]
• Hospital Anxiety and Depression Scale [Time frame: 14 weeks]
• Tampa-Scale of Kinesiophobia [Time frame: 14 weeks]
• 12-Item Short-Form Health Survey [Time frame: 14 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Kırşehir Ahi Evran University — Kırşehir

Publications

• 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. PMID 33675971
• 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. PMID 28400877
• 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. PMID 32833188
• 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. PMID 32573448
• 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. PMID 32661917
• 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. PMID 31811355

Identifiers

NCT: NCT05450510 · 2022500

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗