Back to results

Subacromial Bursa Re-Implantation After Rotator Cuff Repair

Primary Purpose

Rotator Cuff Injuries

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Experimental group(Bursa Implantation)

Control Group(Standard of Care)

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring subacromial bursa

Eligibility Criteria

25 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Change in range of motion

range of motion will be measured using a goniometer

Change in strength of shoulder

shoulder strength will be measured using handheld dynamometer

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

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

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

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)

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

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

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

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

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT04634084

First Posted

November 16, 2020

Last Updated

October 31, 2022

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT04634084

Brief Title

Subacromial Bursa Re-Implantation After Rotator Cuff Repair

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 24, 2021 (Actual)

Primary Completion Date

September 22, 2024 (Anticipated)

Study Completion Date

September 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Injuries

Keywords

subacromial bursa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Title

Control Group

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Experimental group(Bursa Implantation)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Control Group(Standard of Care)

Intervention Description

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 Outcome Measure Information:

Title

Change in range of motion

Description

range of motion will be measured using a goniometer

Time Frame