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.
RECRUITING
NA
60 participants
INTERVENTIONAL
2023-10-30
2027-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions it aims to answer are:
* comparing the outcomes of the two surgical techniques (BRR with an acellular human dermal allograft implant vs Arthroscopic Assisted LTT Transfer) on the maintenance of the acromiohumeral distance
* compare the outcomes of strength, range of motion, and patient reported quality of life scores between the two techniques
Participants will be randomized into one of two surgical treatment groups (bridging reconstruction or lower trapezius tendon transfer) and followed for a minimum of two years to compare the outcomes between groups.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lower Trapezius Tendon Transfer vs Partial Cuff Repair in Massive Rotator Cuff Tears
NCT07051889
Massive Rotator Cuff Tear Reconstruction
NCT03425500
Maximal Repair Versus Bridging Reconstruction with BioBrace®
NCT05959733
Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair
NCT02655848
Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears
NCT01481480
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant. The examination will consist of range of motion testing by goniometer, range of motion testing evaluated by one's reach envelope, as well as strength testing by hand dynamometer. The patient will also complete the Western Ontario Rotator Cuff Index (WORC) questionnaire.
Randomization: Randomization will be done with a computer random number generator. Treatment conditions will be inserted in ordered opaque envelopes. Two groups (bridging reconstruction, and lower trapezius transfer) will be selected with 30 subjects each group.
Surgical Procedures: Wong et al. (2021) described the surgical procedure for patients in the "Bridging" group. The bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed into the remnants of supraspinatus and infraspinatus tendons. The patch is then attached to the greater tuberosity in a double row configuration.
The lower trapezius transfer will be performed as described by Wagner et. al. (2018). Patients will be placed in beach chair position, with the ipsilateral half of the back uncovered for surgical access. A 5-cm vertical skin incision will be made 1 cm from the medial border of scapula by the upper and lower edge of the lower trapezius tendon. The fat area at the inferior edge of the lower trapezius tendon will be identified, and the lower trapezius tendon will be completely released from spine of scapula and medially through opening of the superficial fascia. Two sutures in a Krakow configuration will be placed in the lower trapezius tendon. 2 sutures of different colors will be placed in the thick part of the allograft in a Krakow configuration. Designated ventral and dorsal aspects of the allograft will be marked. The infraspinatus fascia will be opened at the level of the medial incision. The sutures in the thick part of the allograft are then clamped to bring the graft intra-articular. Each of the Krakow sutures placed in the thick end of the allograft are passed to each of the 2 loadable suture anchors to attach the most distal part of the allograft, fixating the graft.
Postoperative protocol: The shoulder will be immobilized in a sling for one week postoperatively, and only passive forward flexion and external rotation will be allowed for eight weeks. The patient then progresses to active shoulder motion. Strengthening will begin at twelve weeks postoperatively. The patient will follow-up with the attending surgeon (IW) at 2 weeks post-operatively for a wound check. Then further clinical follow-up appointments will be at 6 weeks, 3 months, 6 months, 12 and 24 months, as per current clinical practice.
At the 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant who is blinded to the patients' treatment group. The patient will also complete the WORC questionnaire at these follow-up appointments. Radiographs will be taken also to obtain the postoperative measurements. MRI will be done to assess healing at 12 months.
Analysis of Data: The data collected will be analyzed through SPSS version 24. Two-tailed independent t-tests will be performed for the WORC, acromiohumeral distance, range of motion, and strength measures comparing the two groups at most recent postoperative measurement. Repeated-measures ANOVA will be used to assess differences in WORC scores, range of motion and strength within each group between time points.
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
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lower Trapezius Tendon Transfer
The lower trapezius tendon transfer arm will consist of patients randomized to this surgical procedure. This is an arthroscopically assisted open procedure that involves harvesting of the lower trapezius muscle tendon and re-grafting it onto to shoulder to repair massive rotator cuff tears.
Surgical Repair of Large to Massive Rotator Cuff Tears
Surgical procedure to reconstruct the rotator cuff
Bridging Reconstruction Repair
The bridging reconstruction repair arm will consist of patients randomized to this surgical procedure. This operation is arthroscopic, and involves the insertion of a human dermal allograft to the rotator cuff, sutured and anchored in a "bridging" fashion to repair massive rotator cuff tears.
Surgical Repair of Large to Massive Rotator Cuff Tears
Surgical procedure to reconstruct the rotator cuff
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgical Repair of Large to Massive Rotator Cuff Tears
Surgical procedure to reconstruct the rotator cuff
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* tear size \>5cm
* two-tendon, irreparable tear
* competent adult (\>18 years of age)
* \<50% muscle atrophy.
Exclusion Criteria
* glenohumeral osteoarthritis
* WORC score \> 70
* uncontrolled diabetes (Hgb A1C \>7%)
* pregnancy
* presence of local or systemic infection
* inability to cooperate with and/or comprehend post-operative instructions
* cancer
* paralysis of the shoulder
* contracture of the shoulder
* inability to provide informed consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nova Scotia Health Authority
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ivan Wong, MD
MD, FRCS(C), Prinicipal Investigator, Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
5955 Veterans' Memorial Lane Room 2106, VMB
Halifax, Nova Scotia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
52466
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.