Clinical trial NCT03425500: Massive Rotator Cuff Tear Reconstruction
Official title: Bridging Reconstruction of Massive Rotator Cuff Tears by Human Dermal Allograft Augmentation Compared to Superior Capsular Reconstruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rotator Cuff Tear Arthropathy
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.

Detailed description: A total of 60 patients will be enrolled in the study. In the pre-operative period, there will be no additional time requirements for the patient, except for the informed consent process for the study. Routine radiographs including an AP and Y view of the shoulder as well as a pre-operative MRI are obtained for all patients undergoing rotator cuff surgery.

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.

Eligibility criteria: Inclusion Criteria:

* Magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\>3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff

Exclusion Criteria:

* Presence of subscapular tear
* 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

Primary outcomes:
measure: Maintenance of Acromiohumeral Distance
timeFrame: 24 months
Secondary outcomes:
measure: Changes in Shoulder Strength After Surgery
timeFrame: 24 months
measure: Changes in Shoulder Range of Motion After Surgery
timeFrame: 24 months
measure: Changes in Patient Reported Outcomes using the Western Ontario Rotator Cuff Index (WORC)
timeFrame: 24 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Ivan H Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: