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NCT Number: NCT04634084

Subacromial Bursa Re-Implantation After Rotator Cuff Repair

The purpose of this study is to evaluate clinical outcomes, structural integrity, and tendon organization after rotator cuff repair with and without subacromial bursa implantation and to further co-existing research studies performed at The University Of Texas Health Science Center of Houston (UT Health) on Ultrashort Time to Echo-Magnetic Imaging Resonance(UTE-MRI) techniques and their implication for rotator cuff analysis.

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Key information

Conditions

Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Present with rotator cuff tears requiring arthroscopic repair as confirmed by a medical expert
  • Are able to provide informed consent
  • Can commit to study follow-up visits or procedures

Exclusion criteria

  • Are unable to provide informed consent
  • Have additional ipsilateral shoulder complications that will inhibit standard of care treatment and rehabilitation
  • Have active infection at operative site
  • Have active systemic infection
  • Chronic inflammatory condition such as rheumatoid arthritis or lupus
  • Has had a corticosteroid injection to the affected shoulder within the six weeks prior to surgery
  • Have had prior surgical interventions in the past that have modified the existing natural anatomical arrangement of the rotator cuff/shoulder.
  • Non-English speaker

Treatment and study plan

Experimental group(Bursa Implantation)

Procedure

Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.In the experimental group, instead of being discarded, this minced bursal tissue will be collected via a sterile filtration device attached to the oscillating shaver. The bursal tissue is then placed into a sterile syringe, and reimplanted back onto the bursal surface of the rotator cuff repair at the completion of the case. The arthroscopic fluid is turned off, and fluid is evacuated from the shoulder prior to reimplantation of the bursa.. Nothing is added to the bursa prior to reimplantation. There are no reagents. The bursa tissue is purely the minced bursa tissue removed from the patient, and never leaves the sterile field.

Control Group(Standard of Care)

Procedure

Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.The current standard of care procedure is to discard this tissue, and then proceed with the rotator cuff repair

Primary outcomes

  1. Change in range of motion

    Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

    range of motion will be measured using a goniometer

  2. Change in strength of shoulder

    Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

    shoulder strength will be measured using handheld dynamometer

  3. Change in pain of shoulder as measured by the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

    Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

    This is scored form 0-100,lower score means worse pain

  4. Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST)

    Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

    The SST consists of 12 questions with dichotomous (yes/ no) response options. For each question, the patients indicate that they are able or are not able to do the activity. The scores range from 0 (worst) to 12(best)

  5. Change in pain as assessed by the Visual Analog Scale (VAS)

    Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

    The VAS is scored form 0-10, 0 being no pain and 10 being worst pain

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Tests (CATs)

    Time frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

    PROMIS CAT-PF is scored on a scale from 20-80, where a higher number indicates higher function

Secondary outcomes

  1. Number of participants with improvement in structural integrity as assessed by postoperative MRI

    Time frame: 6 months post surgery

  2. Number of participants with improvement in structural integrity as assessed by postoperative MRI

    Time frame: 12 months post surgery

  3. Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.

    Time frame: 6 months post surgery

  4. Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.

    Time frame: 12 months post surgery

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Subacromial Bursa Re-Implantation After Rotator Cuff Repair - A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 18, 2020
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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