Tenotomy Clinical Trials

Clinical trials related to Tenotomy Procedure

Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs On Function, Quality Of Life, And Sleep: A Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This prospective, single-arm interventional study will evaluate the effects of long head of the biceps tendon (LHBT) transposition without tenotomy as an augmentation technique for arthroscopic partial repair in adults with massive rotator cuff tears. Consecutive eligible patients undergoing arthroscopic partial rotator cuff repair plus tenotomy-sparing LHBT transposition augmentation at Balikesir City Hospital (Balikesir, Turkiye) will be enrolled and followed for 12 months. Patient-reported outcomes and clinical assessments will be collected preoperatively (baseline) and postoperatively at 3 and 12 months. The primary outcomes are shoulder function (ASES), rotator cuff-related quality of life (WORC converted to a 0-100 scale), and sleep disturbance (Insomnia Severity Index). Secondary outcomes include active shoulder range of motion and biceps-related clinical findings (Speed test, Yergason test, bicipital groove tenderness, and Popeye deformity). Postoperative MRI will not be obtained routinely and will be performed only if clinically indicated. The study aims to provide standardized prospective data on functional outcomes, quality of life, and sleep after this augmentation approach.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Diagnosis of a massive rotator cuff tear on preoperative MRI, defined as a full-thickness tear involving at least two tendons and/or a tear with a greatest dimension greater than 5 cm

• Planned arthroscopic partial rotator cuff repair with augmentation using tenotomy-sparing long head of the biceps tendon (LHBT) transposition

• Persistence of symptoms despite at least 3 months of standard nonoperative treatment

• Intact LHBT confirmed intraoperatively

• Willingness and ability to attend scheduled follow-up visits (baseline, 3 months, and 12 months)

• Provision of written informed consent

Locations
Other Locations
Turkey
Güneş Sarıkaya
RECRUITING
Balıkesir
Contact Information
Primary
gunes 0 SARIKAYA, M.D
gunessarikaya05@hotmail.com
05436733113
Backup
gunes SARIKAYA
05436733113
Time Frame
Start Date: 2026-03-26
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 35
Treatments
Other: Biceps Transposition Augmentation
Participants in this single arm undergo arthroscopic partial rotator cuff repair augmented with tenotomy-sparing transposition of the long head of the biceps tendon (LHBT). All procedures are performed according to a standardized surgical and rehabilitation protocol.
Related Therapeutic Areas
Sponsors
Leads: Ataturk University

This content was sourced from clinicaltrials.gov