Rotator Cuff TearsNCT05894265
Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
A study testing ActiveMatrix® Dosage A, ActiveMatrix® Dosage B and Saline injection in people with Rotator Cuff Tears, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- ActiveMatrix® Dosage A, ActiveMatrix® Dosage B and Saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 1-2 tendon full thickness reparable rotator cuff tendon tear(s)
- Reparable tear defined as:
- a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension.
- Full-thickness tear defined as:
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- a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border
- Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
- Have no contraindications or allergies to the treatment administered
- Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses
- Able and willing to comply with the post-operative physical therapy and study follow-up schedule
Who cannot join
- Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
- Prior surgery for bone defects requiring bone implantation in the index shoulder,
- Steroid injection into the index shoulder within 6 weeks of enrollment.
- Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
- Calcific tendonitis in the index shoulder,
- Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3,
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- Contralateral shoulder injury that may interfere with the post-operative rotator cuff repair rehab guidelines,
- History of advanced osteoarthritis of glenohumeral joint (AC joint can have advanced OA) i.e. Samilson-Prieto classification ≥ Grade 2
- History of malignant tumor and osseous metastatic disease,
- History of heterotopic ossification,
- History of chronic pain disorders (i.e., fibromyalgia),
- Current substance abuse (drug or alcohol), by the investigator's judgment,
- For females of child-bearing potential: unable or unwilling to take adequate contraceptive precautions during the study, known to be pregnant at enrollment, breastfeeding an infant at enrollment or during the study, or planning to become pregnant during the study,
- Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,
- Currently involved in any injury litigation or workers compensation claims,
- has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Eric F Berkman, MD, 713-314-4112, Eric.F.Berkman@uth.tmc.edu
Layla Haidar, 713-486-5529, Layla.Haidar@uth.tmc.edu
About this study
Official title: Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (Active Matrix) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery
- Conditions
- Rotator Cuff Tears
- Being tested
- ActiveMatrix® Dosage A, ActiveMatrix® Dosage B, Saline injection
- Keywords
- musculoskeletal injuries, rotator cuff repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveMatrix® Dosage AOther
Also called Human Placental Connective Tissue-Derived Allograft
This group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline)
ActiveMatrix® Dosage BOther
Also called Human Placental Connective Tissue-Derived Allograft
Group 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline)
Saline injectionProcedure or surgery
Group 3 will receive saline injection
| Study group | Role | What they receive |
|---|---|---|
| ActiveMatrix® Dosage A | Experimental | Not described Receives: Other: ActiveMatrix® Dosage A |
| ActiveMatrix® Dosage B | Experimental | Not described Receives: Other: ActiveMatrix® Dosage B |
| Saline Injection | Placebo comparator | Not described Receives: Procedure: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Sugaya classification is a classification system that is used to analyze postoperative rotator cuff tendon integrity
Measured: 6 months post surgery , 12 months post surgery
Secondary outcomes (4)
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.PROM will be measured on both sides
Measured: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Change in shoulder function as assessed by the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
The total score is weighted 50% for pain and 50% for function. The pain score is calculated by subtracting the VAS from 10 and multiplying it by 5. The 10 functional questions are scored on a 4-point scale (0-3) with a maximum functional score of 30. The raw functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points. The pain and function scores are then added together to obtain the final ASES score (out of 100). Higher scores correlate to better outcomes.
Measured: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
VAS is scored on a 100mm horizontal scale that represents the patients pain intensity. A higher score corresponds to increased pain intensity
Measured: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI)
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. This contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability and each is scored from 0 = no pain and 10 = the worst pain imaginable. SPADI is scored from 0 to 130 with a high score representing more pain and disability.
Measured: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start14 Jun 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Skye Biologics Holdings, LLC
- Responsible party
- Principal investigator, Eric F Berkman, The University of Texas Health Science Center, Houston
- Investigators
- Eric F Berkman, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894265
- Sponsor's protocol ID
- HSC-MS-23-0312
- Status last verified
- Apr 2026
- First submitted
- 30 May 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (Active Matrix) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT05894265
- Acronym / sponsor ID
- HSC-MS-23-0312
- Conditions
- Rotator Cuff Tears
- Keywords
- musculoskeletal injuries, rotator cuff repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Skye Biologics Holdings, LLC
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 8 Jun 2023 (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.
The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ActiveMatrix® Dosage A | Experimental | Other: ActiveMatrix® Dosage A |
| ActiveMatrix® Dosage B | Experimental | Other: ActiveMatrix® Dosage B |
| Saline Injection | Placebo comparator | Procedure: Saline injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 1-2 tendon full thickness reparable rotator cuff tendon tear(s)
- a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension.
- a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border
Key exclusion criteria (16 listed)
- Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
- Prior surgery for bone defects requiring bone implantation in the index shoulder,
- Steroid injection into the index shoulder within 6 weeks of enrollment.
- Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
- Calcific tendonitis in the index shoulder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiveMatrix® Dosage AAlso: Human Placental Connective Tissue-Derived AllograftThis group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline) | Other | ActiveMatrix® Dosage A |
| ActiveMatrix® Dosage BAlso: Human Placental Connective Tissue-Derived AllograftGroup 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline) | Other | ActiveMatrix® Dosage B |
| Saline injectionGroup 3 will receive saline injection | Procedure or surgery | Saline Injection |
Primary outcome
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Time frame: 6 months post surgery , 12 months post surgery
Sugaya classification is a classification system that is used to analyze postoperative rotator cuff tendon integrity
4 secondary outcomes
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer
Time frame: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Change in shoulder function as assessed by the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time frame: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
Time frame: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI)
Time frame: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
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Voll Non-Degradable Shoulder Spacer FIH Study
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Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
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SMR Stemless Reverse vs SMR Reverse Shoulder System
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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.
Eric F Berkman, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiveMatrix® Dosage A, ActiveMatrix® Dosage B and Saline injection in people with Rotator Cuff Tears, run by The University of Texas Health Science Center, Houston 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 11 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric F Berkman, MD (713-314-4112, Eric.F.Berkman@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI) (time frame: 6 months post surgery , 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.