An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction

Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears. Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Detailed Description

Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears.Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes. We predict there will be significant improvement in radiographic, clinical, and patient reported outcomes in patients undergoing SCR for extensive, primarily irreparable rotator cuff tears when AlloMend allograft is utilized.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Jackie Bader, MS; Phone Number: 303-321-1333; Email: JBader@western-ortho.com
• Study Contact Backup: Name: LIbby Mauter, MS/PT; Phone Number: 303-321-1333; Email: LMauter@western-ortho.com

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Western Orthopaedics Education and Research Foundation
      • Contact: Jackie Bader, MS; Phone Number: 303-321-1333; Email: JBader@western-ortho.com
      • Contact: LIbby Mauter, MS/PT; Phone Number: 303-321-1333; Email: LMauter@western-ortho.com
      • Principal Investigator: Armodios Hatzidakis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with massive rotator cuff tears

Description

Inclusion Criteria:

• Subjects who are undergoing SCR for massive rotator cuff
• Adult patients (≥18)
• Pre-operative MRI obtained within 26 weeks prior to surgery
• Must have 3 out of 5 external rotation strength
• Must have intact teres minor

Exclusion Criteria:

• Worker's Compensation Case
• Persons with a mental or cognitive disability deemed significant enough that they would not be capable of complying with a restricted rehabilitation program or completing the outcome measures
• Patients with known contraindications to MRI
• Pectoralis major, pectoralis minor, deltoid, or latissimus dorsi dysfunction
• Acute fractures of humerus, clavicle, scapula
• Inability to speak and/or understand English

Intra-Op Exclusion Criteria:

• Anterosuperior escape of the glenohumeral joint due to a completely incompetent anterosuperior cuff and coracoacromial ligament (CAL)
• Unable to fix the graft on the humeral side utilizing a double row repair
• Inability to address subscapularis pathology
• Diffuse bipolar cartilage loss

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study Group; Patients treated with Superior Capsular Reconstruction with Allomend

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acromiohumeral interval change	Xrays will be used to compare the amount of superior humeral migration between 12 month xrays and 24 month xrays	24 months
Clinical Failure	Revision Surgery	Within 24 months
Rotator Cuff Integrity and Graft Incorporation	These will be assessed via MRI with Arthrogram- changes will be compared between the 12 and 24 month time points	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function (Activities of Daily Living)	Function will be assessed via the American Shoulder and Elbow Score (0-100; higher score is better)	24 months
Function (Overall Normal rating)	Function will be assessed via the Single Assesment Numeric Evaluation (SANE) (0-100; where 100 is normal)	24 months
Shoulder Pain	Pain will be assessed on a Visual Analog Scale (VAS) (0-10; where 0 is no pain and 10 is the worst pain imaginable)	24 months
Range of Motion	Function will be assessed by measuring active range of motion (forward flexion, abduction, external rotation, internal rotation) with a goniometer	24 months
Resilience	Resilience will be assessed via the Brief Resilience Score (BRS) (scores 1-5; higher score = higher resilience)	24 months

Collaborators and Investigators

• Sponsor: Western Orthopaedics Research and Education Foundation
• Collaborators: AlloSource
• Investigators: Principal Investigator: Armodios Hatzidakis, MD, Western Orthopaedics Education and Research Foundation

Publications and helpful links

General Publications

• Mihata T, McGarry MH, Kahn T, Goldberg I, Neo M, Lee TQ. Biomechanical Role of Capsular Continuity in Superior Capsule Reconstruction for Irreparable Tears of the Supraspinatus Tendon. Am J Sports Med. 2016 Jun;44(6):1423-30. doi: 10.1177/0363546516631751. Epub 2016 Mar 4.
• Adams CR, Denard PJ, Brady PC, Hartzler RU, Burkhart SS. The Arthroscopic Superior Capsular Reconstruction. Am J Orthop (Belle Mead NJ). 2016 Jul-Aug;45(5):320-4.
• Pennington WT, Bartz BA, Pauli JM, Walker CE, Schmidt W. Arthroscopic Superior Capsular Reconstruction With Acellular Dermal Allograft for the Treatment of Massive Irreparable Rotator Cuff Tears: Short-Term Clinical Outcomes and the Radiographic Parameter of Superior Capsular Distance. Arthroscopy. 2018 Jun;34(6):1764-1773. doi: 10.1016/j.arthro.2018.01.009. Epub 2018 Feb 15.
• Polacek M. Arthroscopic Superior Capsular Reconstruction With Acellular Porcine Dermal Xenograft for the Treatment of Massive Irreparable Rotator Cuff Tears. Arthrosc Sports Med Rehabil. 2019 Nov 13;1(1):e75-e84. doi: 10.1016/j.asmr.2019.08.001. eCollection 2019 Nov.
• Burkhart SS, Pranckun JJ, Hartzler RU. Superior Capsular Reconstruction for the Operatively Irreparable Rotator Cuff Tear: Clinical Outcomes Are Maintained 2 Years After Surgery. Arthroscopy. 2020 Feb;36(2):373-380. doi: 10.1016/j.arthro.2019.08.035. Epub 2019 Dec 18.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Rupture
• Other Study ID Numbers: ALLOMEND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: aggregate data

Drug and device information, study documents

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