Outcomes of Massive Rotator Cuff Tendon Tear Treatment.
NCT ID: NCT06016439
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2024-01-31
2033-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study is conducted in Tartu University Hospital Sports Traumatology Centre and rotator cuff repair procedures will be done by three orthopaedic surgeons with long experience in arthroscopic shoulder surgery.
It is determined intra-operatively whether the tear is reparable or not. If possible, the tendon(s) will be anatomically repaired. For irreparable tears intra-operative urn randomization takes place - either partial repair or partial repair with SCR using the LHBB tendon. Surgical techniques will be standardized. Patients who refuse operative treatment, will be followed as conservative treatment group.
The primary objective of the study is the functional status of the included subjects in different treatment groups. The secondary objective of the study is to confirm whether the tendons are intact on follow-up magnetic resonance imaging (MRI) 6 months, 12 months and 24 months after operation using Sugaya classification (2007).
The post-operative therapy regimen will be the same for each study group. Subjects will come for scheduled visits at 6-month, 12-month, and 24-month timepoints. Assessment tools consist of range of motion (ROM), strength measurements, preoperative radiography measuring acromio-humeral index (AHI), critical shoulder angle (CSA), acromion type and shoulder arthrosis (Hamada), functional scores: The Disabilities of the Arm, Shoulder and Hand (DASH), The Constant-Murley score (CMS), The American Shoulder and Elbow Surgeons (ASES) and visual analogue scale (VAS), also including Tampa kinesiophobia score and emotional well-being (EEK) score. Goutallier classification (1994) will be used pre- and postoperatively to measure muscle fatty infiltration.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT
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.
Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT
Residual rotator cuff defect will be reconstructed using LHBBT.
Suture anchor(s)
Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).
Arthroscopic partial rotator cuff repair
If a tear is intra-operatively determined irreparable, randomization takes place.
Irreparable tears that are randomly selected to receive arthroscopic partial repair.
Arthroscopic rotator cuff partial repair
Rotator cuff will be repaired with remaining residual defect.
Suture anchor(s)
Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).
Arthroscopic rotator cuff repair
Arthroscopic complete repair.
Arthroscopic complete rotator cuff repair
Arthroscopic complete repair as a standard procedure.
Suture anchor(s)
Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).
Rotator cuff tear conservative treatment
Conservative treatment following physiotherapy protocol.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT
Residual rotator cuff defect will be reconstructed using LHBBT.
Arthroscopic rotator cuff partial repair
Rotator cuff will be repaired with remaining residual defect.
Arthroscopic complete rotator cuff repair
Arthroscopic complete repair as a standard procedure.
Suture anchor(s)
Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
50 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Tartu
OTHER
Tartu University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tiina Tikk, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tartu
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Tikk23
Identifier Type: -
Identifier Source: org_study_id