Health TrialsbyHealthPanel

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

ConditionsRotator Cuff TearsRotator Cuff Tear Arthropathy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System

About this trial

The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Indicated and scheduled for arthroscopic rotator cuff repair.

Full-thickness medium (1-3 cm), large (3-5 cm), and massive (>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.

Chronic, degenerative rotator cuff tears.

Ability to read and understand English.

Disqualifiers

Patient scheduled for open or mini-open rotator cuff repair

Prior surgery of affected shoulder (except diagnostic arthroscopy)

Partial-thickness rotator cuff tears

Small (<1 cm) rotator cuff tears

Trial design

Design model

Parallel

Treatments tested in this trial

  • arthroscopic rotator cuff repair

    Procedure/Surgery

    This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.

  • Bioinductive implant

    Biological/Vaccine

    A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.

  • Ultrasound Imaging

    Diagnostic test

    An ultrasound will be performed on each patient one year postoperatively.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 2 interventions
Group B: Study GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Rotator cuff repair integrity

absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.

Time frame
Preoperative to 1 year postoperative

Secondary outcomes

1

PROMs scores for upper extremity function

Patient-Reported Outcome Measures (PROMs) scores for upper extremity function. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 0 - 100-point scale, with a score of 50 representing the mean of the population at large, 0 representing the minimum, and 100 representing the maximum function.

Time frame
Preoperative to 2 years postoperative
2

PROMs scores for depression

Patient-Reported Outcome Measures (PROMs) scores for depression. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher increased depression (worse).

Time frame
Preoperative to 2 years postoperative
3

PROMs scores for upper extremity pain interference

Patient-Reported Outcome Measures (PROMs) scores for upper extremity pain and how it interferes with the patients daily life. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher pain interference (worse).

Time frame
Preoperative to 2 years postoperative
4

Shoulder Range of Motion

Standard range of motion values collected by the surgeon during preoperative and followup visits

Time frame
Preoperative to 2 years postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

Source ClinicalTrials.gov
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