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Placental graft could boost shoulder surgery success

NCT ID NCT05894265

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special graft made from donated placental tissue, called ActiveMatrix, can help the shoulder tendon heal better after rotator cuff repair surgery. About 72 people with a full-thickness tear in 1 or 2 tendons will be randomly assigned to get either a low or high dose of the graft, or a plain saline injection during surgery. The main goal is to see if the graft leads to a more intact tendon on MRI and better shoulder movement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ActiveMatrix (human placental connective tissue-derived allograft)
What this could lead to
If it works, this could lead to a better healing and recovery after rotator cuff surgery, reducing the chance of re-tear.
What could go wrong
This is a small, early pilot study, so results may not apply to everyone. The graft might not improve healing more than standard care, and there are risks from surgery itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 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 Exclusion Criteria: * 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, * 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.

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

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