Acellular Dermis in Rotator Cuff Repair

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05458349

Enrollment

Registered

2022-07-14

Start date

2013-04-04

Completion date

2021-02-11

Last updated

2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Injuries, Rotator Cuff Tears

Keywords

rotator cuff, shoulder, surgery, acellular dermal graft, acellular dermis, rotator cuff augmentation

Brief summary

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

Detailed description

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

Interventions

DEVICEacellular dermis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

It is a Level 1 study, a prospective double blind, randomized controlled trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Symptomatic rotator cuff tear that warrants operative intervention. 2. A Tear measuring between 1-5cm at arthroscopy. 3. An arthroscopic rotator cuff repair. 4. Written consent.

Exclusion criteria

1. Rotator cuff tears greater than 5cm and less than 1cm 2. Clinical or radiological evidence of osteoarthritis affecting the index side. 3. Patients involved in a Compensation claim related to the shoulder. 4. Inability to attend follow-up for 1 year and to a repeat MRI scan. 5. Previous shoulder surgery or proximal humeral fracture on the index side. 6. Patients that are recruited in a current study

Design outcomes

Primary

Measure	Time frame	Description
rotator cuff healing	12 month post-surgery	Rotator cuff healing on MRI

Secondary

Measure	Time frame	Description
Western Ontario Rotator cuff score	12months	comparison of scores between groups
Constant Murley score	12 months	comparison of scores between groups
American shoulder and elbow surgeons standardized form	12 months	comparison of scores between groups

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026