Rotator Cuff Tear or Rupture, Not Specified as TraumaticNCT04615117
An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction
An observational study of Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by Western Orthopaedics Research and Education Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with massive rotator cuff tears
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Western Orthopaedics Education and Research Foundation
Denver, Colorado, 80218
Jackie Bader, MS, 303-321-1333, JBader@western-ortho.com
LIbby Mauter, MS/PT, 303-321-1333, LMauter@western-ortho.com
About this study
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.
Read the 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.
- Medical subject headings
- Rotator Cuff Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients treated with Superior Capsular Reconstruction with Allomend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acromiohumeral interval change
Xrays will be used to compare the amount of superior humeral migration between 12 month xrays and 24 month xrays
Measured: 24 months
Clinical Failure
Revision Surgery
Measured: 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
Measured: 24 months
Secondary outcomes (5)
Function (Activities of Daily Living)
Function will be assessed via the American Shoulder and Elbow Score (0-100; higher score is better)
Measured: 24 months
Function (Overall Normal rating)
Function will be assessed via the Single Assesment Numeric Evaluation (SANE) (0-100; where 100 is normal)
Measured: 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)
Measured: 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
Measured: 24 months
Resilience
Resilience will be assessed via the Brief Resilience Score (BRS) (scores 1-5; higher score = higher resilience)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Aug 2021
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Tear or Rupture, Not Specified as TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Western Orthopaedics Research and Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- AlloSource
- Responsible party
- Sponsor
- Investigators
- Armodios Hatzidakis, MD, Principal investigator, Western Orthopaedics Education and Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615117
- Sponsor's protocol ID
- ALLOMEND
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: aggregate data
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.
PubMed 26944572Adams 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.
PubMed 27552457Pennington 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.
PubMed 29456069Polacek 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.
PubMed 32266343Burkhart 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.
PubMed 31864817
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction
- ClinicalTrials.gov ID
- NCT04615117
- Acronym / sponsor ID
- ALLOMEND
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Western Orthopaedics Research and Education FoundationUniversity, hospital or other
- Collaborators
- AlloSource
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Patients treated with Superior Capsular Reconstruction with Allomend |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with massive rotator cuff tears
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acromiohumeral interval change
Time frame: 24 months
Xrays will be used to compare the amount of superior humeral migration between 12 month xrays and 24 month xrays
Clinical Failure
Time frame: Within 24 months
Revision Surgery
Rotator Cuff Integrity and Graft Incorporation
Time frame: 24 months
These will be assessed via MRI with Arthrogram- changes will be compared between the 12 and 24 month time points
5 secondary outcomes
Function (Activities of Daily Living)
Time frame: 24 months
Function (Overall Normal rating)
Time frame: 24 months
Shoulder Pain
Time frame: 24 months
Range of Motion
Time frame: 24 months
Resilience
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Results publication: PubMed 26944572Mihata 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.
- Results publication: PubMed 27552457Adams 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.
- Results publication: PubMed 29456069Pennington 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.
- Results publication: PubMed 32266343Polacek 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.
- Results publication: PubMed 31864817Burkhart 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.
- Individual participant dataSharing planned: No. aggregate data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armodios Hatzidakis, MD principal investigator
Western Orthopaedics Education and Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear or Rupture, Not Specified as Traumatic, run by Western Orthopaedics Research and Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jackie Bader, MS (303-321-1333, JBader@western-ortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acromiohumeral interval change (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615117, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.