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OpenTrials
Completed

NCT Number: NCT05458349

Acellular Dermis in Rotator Cuff Repair

To determine if an acellular dermal graft (ADG) will incorporate into the rotator cuff and subsequently improve outcomes without an increase in risk to the patient

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Orthopaedic Hospital NHS Trust

Birmingham, United Kingdom

About this study

Rotator cuff healing poses a significant clinical problem with re-tear rates between 20-50%. The final functional outcome following surgery correlates with healing, with those that completely heal performing best. Failure of repair is mainly due to tendon failure both mechanically and biologically. If the healing and the structural properties of the tendon can be improved then significant functional gains may be achieved. This study will therefore utilise acellular dermal grafts to determine whether they could be used for to improve patient outcomes following surgery

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic rotator cuff tear that warrants operative intervention.
  • A Tear measuring between 1-5cm at arthroscopy.
  • An arthroscopic rotator cuff repair.
  • Written consent.

Exclusion criteria

  • Rotator cuff tears greater than 5cm and less than 1cm
  • Clinical or radiological evidence of osteoarthritis affecting the index side.
  • Patients involved in a Compensation claim related to the shoulder.
  • Inability to attend follow-up for 1 year and to a repeat MRI scan.
  • Previous shoulder surgery or proximal humeral fracture on the index side.
  • Patients that are recruited in a current study

Treatment and study plan

acellular dermis

Device

Primary outcomes

  1. rotator cuff healing

    Time frame: 12 month post-surgery

    Rotator cuff healing on MRI

Secondary outcomes

  1. Western Ontario Rotator cuff score

    Time frame: 12months

    comparison of scores between groups

  2. Constant Murley score

    Time frame: 12 months

    comparison of scores between groups

  3. American shoulder and elbow surgeons standardized form

    Time frame: 12 months

    comparison of scores between groups

Sponsors and collaborators

Lead sponsor

The Royal Orthopaedic Hospital NHS Trust

Other

Registry information

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2022
Registry last updated
Jul 14, 2022

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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