Acellular Dermis in Rotator Cuff Repair | NCT05458349

Studies
Acellular Dermis in Rotator Cuff Repair

NCT05458349

Sponsor

The Royal Orthopaedic Hospital NHS Trust

Status

Completed

Last Update Posted

Jul 14, 2022Actual

Enrollment

63Actual

Phase

Not Applicable

Conditions

Rotator Cuff Tears
Rotator Cuff Injuries

Interventions

acellular dermis

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2013Actual

Primary Completion Date

Feb 11, 2021Actual

Completion Date

Feb 11, 2021Actual

First Submitted Date

Jul 11, 2022

First Submission Date that Met QC Criteria

Jul 11, 2022

First Posted Date

Jul 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2022

Last Update Posted Date

Jul 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dermis group	Experimental	Group will receive standard of care treatment and interventions plus the use of the acellular dermal graft during surgery	Device: acellular dermis
control group	No Intervention	Group will receive standard of care treatment and interventions but the acellular dermal graft will not be used during surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acellular dermis	Device		dermis group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Western Ontario Rotator cuff score	comparison of scores between groups	12months
Constant Murley score	comparison of scores between groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martyn Mr Snow, MD	The Royal Orthopaedic Hospital NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Royal Orthopaedic Hospital NHS Trust		Birmingham			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070636	Rotator Cuff Injuries

Ancestor Terms

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries

Browse Leaves

Not provided

Browse Branches

Not provided