Clinical trial NCT04615117: An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction
Official title: An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Lead sponsor: Western Orthopaedics Research and Education Foundation
Sponsor class: OTHER
Collaborators: name: AlloSource
First posted: 2020-11-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with massive rotator cuff tears

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acromiohumeral interval change
timeFrame: 24 months
measure: Clinical Failure
timeFrame: Within 24 months
measure: Rotator Cuff Integrity and Graft Incorporation
timeFrame: 24 months
Secondary outcomes:
measure: Function (Activities of Daily Living)
timeFrame: 24 months
measure: Function (Overall Normal rating)
timeFrame: 24 months
measure: Shoulder Pain
timeFrame: 24 months
measure: Range of Motion
timeFrame: 24 months
measure: Resilience
timeFrame: 24 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Western Orthopaedics Education and Research Foundation
state: Colorado
Study officials:
affiliation: Western Orthopaedics Education and Research Foundation
name: Armodios Hatzidakis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.