Patch Study (Patch-augmented Rotator Cuff Repair)

NCT06076902 | Recruiting

• 1 other identifier: ProjectID 2023-00238
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.

Conditions

Rotator Cuff Tears

Keywords

Rotator Cuff Repair

Outcome Measures

Primary Outcomes (1)

• Rotator cuff retear rate

  Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound)

  Up to two years postoperative

Secondary Outcomes (4)

• Complication rate (adverse event greater than grade 2)

  Up to two years postoperative

• Pain levels

  Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)

• Healing rate

  6-week and 1-year exams (postoperative)

• Range of motion

  Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)

Study Arms (2)

Treatment group with patch augmentation

EXPERIMENTAL

Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch

Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))

Comparison group without patch augmentation

ACTIVE COMPARATOR

Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch

Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch

Interventions

Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)) DEVICE

The Pitch-Patch is a single-use device intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue.

Also known as: Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)

Treatment group with patch augmentation

Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch DEVICE

Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch.

Comparison group without patch augmentation

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with massive rotator cuff tear
• Tear must affect at least two tendons
• Primary surgery only
• Origin of tear can be either degenerative or traumatic
• German language speaking

You may not qualify if:

• Fatty infiltration grade 4 (according to Goutallier)
• Bilateral tears
• Cases of arthritis or severe osteoarthritis
• Structural or pathological condition of the bone or soft tissue that could impair healing
• Unable or unwilling to restrict activities to prescribed levels or follow rehabilitation guidelines
• Unable or unwilling to give consent (language barrier or cognitive impairment)
• Unwilling or unable to be assessed at 1- and 2-year follow-up assessment visits

Sponsors & Collaborators

• Spital Thurgau AG: lead

Study Sites (1)

Spital Thurgau AG

Frauenfeld, Thurgau, 8501, Switzerland

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Florian Hess, MD

  Spital Thurgau AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Hess, MD

CONTACT

+41 58 144 8143; florian.hess@stgag.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind study in which only patients will not be aware of treatment (with or without rotator cuff augmentation with polyester patch)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 11, 2023
• Study Start: April 6, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

CH (1)