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.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-05-01
2025-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lower Trapezius Transfer vs Bridging Reconstruction
NCT05925881
Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone
NCT01987973
Maximal Repair Versus Bridging Reconstruction with BioBrace®
NCT05959733
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
NCT05981833
Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation
NCT04975581
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 as well as strength testing by hand dynamometer. The patient will also complete the WORC questionnaire.
Surgical Technique
All patients will undergo a 15-point arthroscopic shoulder examination as per the method outlined by Snyder. An arthroscopic acromioplasty will be performed if needed according to the technique described by Snyder. The bursal side of the tear will be evaluated. If the cuff can be re-approximated to its anatomic position on the greater tuberosity without excessive tension, a standard rotator cuff reconstruction will be attempted. If this is not possible the surgeon will determine that the cuff is "irreparable" and the randomization envelope will be opened.
Wong et al. 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 technique described by Burkhart et al will be followed for patients in the "SCR" 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. Measurement of defect size (coronal and sagittal) will take place, following that the glenoid and humeral footprint preparation will be performed utilizing an arthroscopic burr, arthroscopic bone anchors will be inserted on the glenoid footprint and graft is inserted with double pully technique. The graft is then tensioned to greater tuberosity using a double row configuration.
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 follow-up appointments will be at 6 weeks, 3 months, 6 months, 12 and 24 months, as per current clinical practice.
At the 3, 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. Radiograph will be taken also to obtain the postoperative measurements. MRI will be done to assess healing at 12 months.
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
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bridging Rotator Cuff Group
Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using GRAFTJACKET™ allograft.
Bridging Rotator Cuff Reconstruction
Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using a GRAFTJACKET™ allograft
GRAFTJACKET™ allograft
The acellular human dermal allograft in used in the bridging rotator cuff reconstruction
Superior Capsular Group
Superior Capsular Reconstruction of massive rotator cuff tear
Superior Capsular Reconstruction
Superior Capsular Reconstruction of massive rotator cuff tear
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bridging Rotator Cuff Reconstruction
Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using a GRAFTJACKET™ allograft
Superior Capsular Reconstruction
Superior Capsular Reconstruction of massive rotator cuff tear
GRAFTJACKET™ allograft
The acellular human dermal allograft in used in the bridging rotator cuff reconstruction
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Presence of glenohumeral osteoarthritis
* WORC score \> 70%
* Uncontrolled diabetes
* Pregnancy
* Presence of local or systemic infection
* Paralysis of the shoulder
* Poor nutritional state
* Contracture of the shoulder
* Presence of cuff tear arthropathy
* MRI proven nonvascular surgical sites
* Cancer
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
Orthopaedic Surgeon MD FRCS(C), Dip. Sports Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ivan H Wong, MD
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IW-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.