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Subacromial Bursa Re-Implantation After Rotator Cuff Repair

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Rotator Cuff Injuries

Treatments

Procedure: Experimental group(Bursa Implantation)
Procedure: Control Group(Standard of Care)

Study type

Interventional

Funder types

Other

Identifiers

NCT04634084
HSC-MS-19-1092

Details and patient eligibility

About

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.

Enrollment

67 patients

Sex

All

Ages

25 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

67 participants in 2 patient groups

Experimental group
Experimental group
Treatment:
Procedure: Experimental group(Bursa Implantation)
Control Group
Active Comparator group
Treatment:
Procedure: Control Group(Standard of Care)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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