Massive Rotator Cuff Tear Reconstruction (SCR)

Bridging Reconstruction of Massive Rotator Cuff Tears by Human Dermal Allograft Augmentation Compared to Superior Capsular Reconstruction

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Tear Arthropathy
• Intervention / Treatment: Procedure: Bridging Rotator Cuff Reconstruction; Device: GRAFTJACKET™ allograft; Procedure: Superior Capsular Reconstruction

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2E1
      • Nova Scotia Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bridging Rotator Cuff Group; Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using GRAFTJACKET™ allograft.	Procedure: Bridging Rotator Cuff Reconstruction; Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using a GRAFTJACKET™ allograft; Device: GRAFTJACKET™ allograft; The acellular human dermal allograft in used in the bridging rotator cuff reconstruction; Other Names: Acellular human dermal allograft
Active Comparator: Superior Capsular Group; Superior Capsular Reconstruction of massive rotator cuff tear	Procedure: Superior Capsular Reconstruction; Superior Capsular Reconstruction of massive rotator cuff tear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of Acromiohumeral Distance	The primary objective of this study is to compare the effect between the two surgical techniques, arthroscopic SCR for a massive, chronic irreparable tear of the rotator cuff vs. BRR with an acellular human dermal allograft implant, on the maintenance of the Acromiohumeral distance. Acromiohumeral Distance is measured in mm and determine through xray.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Shoulder Strength After Surgery	Changes in Strength After Surgery will be measured in kilograms using a hand dynamometer.	24 months
Changes in Shoulder Range of Motion After Surgery	Changes in Shoulder Range of Motion After Surgery will be measured in degrees using a goniometer.	24 months
Changes in Patient Reported Outcomes using the Western Ontario Rotator Cuff Index (WORC)	The Western Ontario Rotator Cuff Index is a questionnaire use to evaluate patient reported outcomes. The questionnaire asks 21 questions are using a 100mm visual analogue type scale patients are asked to indicate how much pain they are experiencing doing different activities. The left end of the line indicates no pain, the right end of the line indicates extreme pain. The distance in mm from the left end of the line determines the amount of pain. To total distances for all 21 questions is added up then subtracted from 2100 and divided by 21 to give a percentage. A percentage of 100 indicates that no pain is being felt and low percentages indicates the patient is experiencing extreme pain.	24 months

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Ivan H Wong, MD, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Crystal Arthropathies; Chondrocalcinosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: IW-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No