Acellular Dermis in Rotator Cuff Repair

Rotator Cuff Tears Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05458349
• Other study ID #: ROH11ORTH09
• Status: Completed
• Phase: N/A
• Start date: April 4, 2013
• Est. completion date: February 11, 2021

Study information

• Verified date: July 2022
• Source: The Royal Orthopaedic Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Device:
• acellular dermis

Locations

Country	Name	City	State
United Kingdom	The Royal Orthopaedic Hospital NHS Trust	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Orthopaedic Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rotator cuff healing	Rotator cuff healing on MRI	12 month post-surgery
Secondary	Western Ontario Rotator cuff score	comparison of scores between groups	12months
Secondary	Constant Murley score	comparison of scores between groups	12 months
Secondary	American shoulder and elbow surgeons standardized form	comparison of scores between groups	12 months