LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair

Phase 4

Terminated

Conditions: Rotator Cuff Tear

Interventions: Procedure: Control
Procedure: ArthroFLEX ECM scaffold graft
Biological: Alternative Treatment Group

Registration Number: NCT03551509

Lead Sponsor: Gregory Gilot

Brief Summary: This trial is to evaluate the effectiveness of the ArthroFLEX® ECM scaffold graph as an augment in rotator cuff repair surgery to reduce the failure rate of rotator cuff repairs for large and massive rotator cuff tears.

Detailed Description: This is a prospective, randomized, controlled, multi-center clinical trial to evaluate the effectiveness of an ECM scaffold graft to augment repair of a large/massive rotator cuff tear. The study will involve 70 patients. 35 patients will be randomly assigned to each arm of the study.

Despite advances in surgical technology, repairs of large (3-5 cm) and massive (\>5 cm) rotator cuff tears (RCT) fail between 20%-90% of the time \[1\]. Due to their size and increased structural involvement, large or massive RCT present a substantial challenge to orthopaedic surgeons. \[16\] The repairs tend to fail at the suture-tendon junction, which is due to several factors, including tension at the repair and quality of the tendon \[1-2,5\]. Full thickness tears are uncommon in younger patients, especially those less than forty years old and are usually traumatic in etiology. Younger patients also typically fair better following arthroscopic rotator cuff repair with fewer failures and more successful return to pre-injury level of function \[16\]. One strategy to augment repair of large to massive rotator cuff tears has been the development of biological scaffold materials, which are composed of extracellular matrix (ECM). The ECM composing the scaffolds are made from a number of tissues, including, but not limited to, small intestinal submucosa (SIS), dermis, and pericardium \[3\]. Studies to date include both prospective and retrospective in animal and human models, and include Restore, a porcine-derived SIS by DePuy Orthopaedics, GraftJacket, a human-derived, non-cross-linked dermis graft by Wright Medical Technology, and Zimmer Collagen Repair, a cross-linked porcine derived dermal graft made by Zimmer. Restore studies have shown no benefit and some even an increase in repair failure with recommendations not to use to augment repair. GraftJacket studies have shown a reduction in graft failure; however, several of the Restore and GraftJacket studies are limited by a lack of a control cohort. The Zimmer graft studies have conflicting results with both an improvement and no improvement in failure rates of repair. The prior studies listed are all in vivo; however, the majority are not randomized trials and thus do not have a control with which to compare data. In addition, some trials include open repairs. A lack of prospective, randomized, controlled, in vivo trials exist that evaluate the ability of the ECM scaffold graft augmentation in large to massive arthroscopic rotator cuff repairs to decrease the failure rate.

The purpose of this study is to evaluate the efficacy of using the Arthroflex (A-FLEX) graft to augment large to massive arthroscopic rotator cuff repairs in vivo and decrease repair failures in a prospective, randomized, controlled trial. By undergoing serial US examinations at follow-ups, we also intend to evaluate when during the postoperative period the failure of the repair occurs.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 9

Inclusion Criteria

Patients with a large (2.5-5 cm) to massive (>5 cm) rotator cuff tear who will be undergoing open or arthroscopic repair. The cuff tear size will be determined on either pre-operative magnetic resonance imaging (MRI), or ultrasound (US), or intra-operative measurements, or computerized tomography (CT).
Patients who are willing and able to provide written informed consent for their involvement in the study.
Patients who meet criteria for RCR surgery
Patients older than 18 years of age

Exclusion Criteria

Those with a known sensitivity to materials of porcine origin.
Patients with addiction to illegal drugs, solvents or alcohol who are actively using or have previously attempted and failed a treatment program.
Patients with bacteremia, a systemic infection, or infection of the surgical site.
All those who are prisoners.
Patients who are pregnant or nursing.
All those with a condition that may limit a patient's ability to finalize the study or that may cause an undue risk to the patient's health and well-being.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Treatment Group	Control	Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used.
Treatment Group	ArthroFLEX ECM scaffold graft	Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff.
Alternative Treatment Group	Alternative Treatment Group	Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.

Primary Outcome Measures

Name	Time	Method
Tendon Healing	As assessed 1 year postoperatively.	Success as defined by tendon healing after rotator cuff repair, as indicated based on MRI
Comparison of Healing by MRI vs US	As assessed 1 year postoperatively.	Comparison of tendon healing will be assessed using US imaging modalities versus MRI (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)
Progress of Tendon Healing	As assessed at 9 months postoperatively.	Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

Secondary Outcome Measures

Name	Time	Method
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	1 year after surgery	The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	1 year after surgery	A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.
Patient Outcomes: Measurement of Shoulder Activity Level	1 year after surgery	This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.
Patient Outcomes: Subjective Shoulder Value (SSV)	1 year after surgery	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.
Patient Outcomes: Constant Score (CS)	1 year after surgery	C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	1 year after surgery	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	1 year after surgery	The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.