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Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

NCT ID: NCT04975581

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-03

Study Completion Date

2024-09-30

Brief Summary

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The Investigators are planning to conduct a Pilot study of 40 patients of Pragmatic randomised controlled trial comparing rotator cuff tendons repair (small tendons around the shoulder ) with or without augmentative patch. It includes patients between age groups 50 to 75 years with large (≥ 3cm and \< 5 cm ) rotator cuff tear that can be fully repaired using open or mini open repair with or without an augmentation with a human dermal matrix allograft (processed skin graft from a human donor ). The main aim is to examine whether the addition of the patch helps to reduce the rate of re-tear of the rotator cuff tendons at one year following surgery. Patients are randomized to receive either a repair with addition of an augmentative patch or a repair without a patch and have an identical follow-up after surgery. Patients are followed up in outpatient at 6 weeks , 3 months and 12 months after randomization and receive an Magnetic Resonant Imaging (MRI) scan 12 months after surgery. The primary outcome measure is to assess the Re-tear rate of rotator cuff at 12 months after surgery. The secondary outcome measure is to assess functional scores of the shoulder at 12 months . The tertiary outcome measures are to check the cost effectiveness of each procedure.

Detailed Description

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The Investigators are planning to conduct a Pilot study of 40 patients of Pragmatic randomised controlled trial comparing rotator cuff tendons repair (small tendons around the shoulder ) with or without augmentative patch. It includes patients between age groups 50 to 75 years with large (≥ 3cm and \< 5 cm ) rotator cuff tear that can be fully repaired using open or mini open repair with or without an augmentation with a human dermal matrix allograft (processed skin graft from a human donor ). The main aim is to examine whether the addition of the patch helps to reduce the rate of re-tear of the rotator cuff tendons at one year following surgery. Patients are randomized to receive either a repair with addition of an augmentative patch or a repair without a patch and have an identical follow-up after surgery. Patients are followed up in outpatient at 6 weeks , 3 months and 12 months after randomization and receive an Magnetic Resonant Imaging (MRI) scan 12 months after surgery. The primary outcome measure is to assess the Re-tear rate of rotator cuff at 12 months after surgery. The secondary outcome measure is to assess functional scores of the shoulder at 12 months . The tertiary outcome measures are to check the cost effectiveness of each procedure.

Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Rotator cuff repair Surgery with Augmentative patch

Open rotator cuff repair Surgery with additional application of augmentative human allograft patch

Group Type EXPERIMENTAL

Allograft Patch

Intervention Type BIOLOGICAL

Rotator Cuff repair with Allograft Patch (Graftjacket Now)

Rotator cuff repair surgery

Open Rotator cuff repair surgery

Group Type ACTIVE_COMPARATOR

Allograft Patch

Intervention Type BIOLOGICAL

Rotator Cuff repair with Allograft Patch (Graftjacket Now)

Interventions

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Allograft Patch

Rotator Cuff repair with Allograft Patch (Graftjacket Now)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Patient aged at least 50 years to 75 years.
2. Degenerative cuff tear.
3. Large Full thickness rotator cuff tear (≥ 3cm and \< 5 cm ) that is fully repairable.
4. Tears diagnosed using MRI scan.
5. Ability to consent.
6. Agreement to use of human dermal matrix allograft as augmentative patch

Exclusion Criteria

1. Previous surgery on the affected shoulder.
2. Osteoarthritic changes.
3. Unable to have MRI Scans.
4. Significant neck pathology.
5. Cognitive problems or language issue.
6. Systemic arthritis
7. Significant dual pathology in the involved shoulder
8. Acute Traumatic tears (\< 6 months since injury).
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals, Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hopsitals of Leicester NHS Trust

Leicester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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UHL Sponsor

Role: CONTACT

[email protected]
+44 116 258 8239 (1823)

Facility Contacts

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UHL Sponsor

Role: primary

+44 116 258 8239(1823)

Other Identifiers

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EDGE ID 139197

Identifier Type: -

Identifier Source: org_study_id