Outcomes of Massive Rotator Cuff Tendon Tear Treatment.

NCT06016439 | Not Yet Recruiting

• 1 other identifier: Tikk23
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable tears. Arthroscopic partial repair has been widely used and superior capsular reconstruction (SCR), either with allograft, autograft or augmentation with long head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results, but lacking high quality evidence. This is a prospective clinical study to compare the outcomes of different surgical methods for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable tears a method will be randomly assigned intra-operatively once a tear is determined to be irreparable - either partial repair or partial repair with superior capsular reconstruction using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but refuse operative treatment, will serve as conservative study group. The hypothesis is that massive rotator cuff tears that are reparable will have the best functional outcomes. For irreparable tears, augmentation with LHBBT will give superior results over partial repair.

Conditions

Rotator Cuff Tears; Rotator Cuff Syndrome

Keywords

rotator cuff injury; rotator cuff tears; massive; shoulder; shoulder injuries; superior capsular reconstruction; long head of biceps tendon; irreparable; tear; rupture; partial repair

Outcome Measures

Primary Outcomes (6)

• Change in shoulder strength

  Measured by the change in rotator cuff strength isokinetic testing (abduction, internal and external rotation).

  Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit

• Change in shoulder range of motion.

  Measured by the change in shoulder range of motion (abduction, internal and external rotation).

  Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit

• Functional outcome according to the American Shoulder and Elbow Surgeons (ASES) score.

  Measured by the change in joint functional score. The higher the score, the better the outcome. The patient self-assessment (pASES) includes 6 pain items and 10 functional items that are shoulder specific (Angst, 2008). The pASES form has 3 sections: pain, instability, activities of daily living (ADLs) (Goldhahn, 2008). Pain section: 4 questions with yes/no responses, 1 question covering number of pain tablets per day, and a VAS (visual analogue scale) from 0 (no pain) to 10 (worst pain). Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)). Activities of daily living (ADLs): Each shoulder is included (affected/non affected), 10 items, with a 4 point ordinal scale, range: 0 (unable to perform activity) to 3 (no difficulty in doing activity) (Goldhahn 2008).

  Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit

• Functional outcome according to the Constant-Murley score (CMS).

  Measured by the change in joint functional score. The higher the score, the higher the quality of the function. The test is divided into four subscales: pain (15 points), activities of daily living (ADL) (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).

  Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit

• Functional outcome according to the Disabilities of the Arm, Shoulder and Hand (DASH).

  Measured by the change in joint functional score. The higher the score, the more severe disability. 30-item self-report questionnaire designed to assess symptoms and function of the entire upper extremity. Total scores range from 0 (minimum) to (100) maximum.

  Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit

• Change in pain score

  Measured by the change in pain score according to the visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain).

  Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit

Secondary Outcomes (3)

• Integrity of surgically repaired rotator cuff tendons on MRI studies using Sugaya classification (2005).

  postoperatively 6 months, 12 months and 24 months

• Change in quality of life

  Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit

• Change in kinesiophobia score

  Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit

Study Arms (4)

Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT

EXPERIMENTAL

If a tear is intra-operatively determined irreparable, randomization takes place. Irreparable tears that are randomly selected to receive arthroscopic rotator cuff partial repair including superior capsular augmentation with proximal part of the long head of the biceps tendon. The long head of the biceps tendon will be released from bicipital groove and proximal part of the tendon will be used to cover the rotator cuff gap and anchored to the greater tuberosity.

Procedure: Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT; Device: Suture anchor(s)

Arthroscopic partial rotator cuff repair

ACTIVE COMPARATOR

If a tear is intra-operatively determined irreparable, randomization takes place. Irreparable tears that are randomly selected to receive arthroscopic partial repair.

Procedure: Arthroscopic rotator cuff partial repair; Device: Suture anchor(s)

Arthroscopic rotator cuff repair

OTHER

Arthroscopic complete repair.

Procedure: Arthroscopic complete rotator cuff repair; Device: Suture anchor(s)

Rotator cuff tear conservative treatment

NO INTERVENTION

Conservative treatment following physiotherapy protocol.

Interventions

Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT PROCEDURE

Residual rotator cuff defect will be reconstructed using LHBBT.

Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT

Arthroscopic rotator cuff partial repair PROCEDURE

Rotator cuff will be repaired with remaining residual defect.

Arthroscopic partial rotator cuff repair

Arthroscopic complete rotator cuff repair PROCEDURE

Arthroscopic complete repair as a standard procedure.

Arthroscopic rotator cuff repair

Suture anchor(s) DEVICE

Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).

Arthroscopic partial rotator cuff repair; Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT; Arthroscopic rotator cuff repair

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Massive rotator cuff tendon tear: grade III according to Davidson and Burkhart 2010 classification, diagnosed on MRI, and LHBB tendon is intact.
• Primary rotator cuff pathology AND
• Symptoms have not lasted more than 6 months.
• In case of trauma, traumatic event no more than 6 months ago.
• Aged between 50 and 80 at the time of enrollment.
• Subject is able and willing to give informed consent AND
• Subject is physically and mentally willing and able to comply with the post-operative rehabilitation protocol, questionnaires, and scheduled clinical and radiographic visits.

You may not qualify if:

• Previous rotator cuff surgery of the index shoulder.
• Acute or chronic osteomyelitis.
• Inflammatory joint disease (rheumatoid arthritis/ (pseudo)gout arthritis).
• Uncontrolled diabetes.
• Active oncological disease.
• Radiologically stage IV shoulder joint arthrosis (rotator cuff arthropathy).
• Systemic or intra-articular corticosteroid therapy less than 60 days prior to planned operation date.
• Intramuscular or peroral corticosteroid treatment less than 30 days prior to planned operation date.
• Acute or chronic conditions that are contraindications for functional testing.
• MRI contraindicated.
• Substance or alcohol abuse.
• Refusal or withdrawal of consent.

Sponsors & Collaborators

• Tartu University Hospital: lead
• University of Tartu: collaborator

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Injuries; Lacerations; Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries; Tendon Injuries

Study Officials

• Tiina Tikk, MD

  University of Tartu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiina Tikk, MD

CONTACT

55929399; tiinatikk@gmail.com

Madis Rahu, PhD/MD

CONTACT

madis.rahu@regionaalhaigla.ee

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 29, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share