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NCT Number: NCT06076902

Patch Study (Patch-augmented Rotator Cuff Repair)

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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

The Pitch-Patch is a single-use synthetic polyester patch (Pitch-Patch, neoligamentsTM, Leeds, UK) intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue. The surgical group will be randomly assigned, and each group will include 150 patients. After surgery, patients will be followed for two years and undergo clinical and radiological assessments.

The main research question to be answered by this investigation is whether synthetic patch augmentation can significantly improve outcomes in patients with rotator cuff tears from either degenerative or traumatic origins versus patients with no patch augmentation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)

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.

Primary outcomes

  1. Rotator cuff retear rate

    Time frame: Up to two years postoperative

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

Secondary outcomes

  1. Complication rate (adverse event greater than grade 2)

    Time frame: Up to two years postoperative

    Development of postoperative complications following rotator cuff reconstruction to treat massive tear

  2. Pain levels

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

    During clinical assessments, patient reported pain levels will be measured using visual analogue scale (VAS); scale 0 (low) to 15 (high)

  3. Healing rate

    Time frame: 6-week and 1-year exams (postoperative)

    Using radiological imaging (ultrasound), healing of the rotator cuff tear will be monitored over time

  4. Range of motion

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

    Clinical assessments of healing using the range of motion will be compared over time

Study contacts

Contact information is provided by the study sponsor or research team.

Florian Hess, MD

CONTACT

[email protected]

+41 58 144 8143

Sponsors and collaborators

Lead sponsor

Spital Thurgau AG

Other

Registry information

Official study title

Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 11, 2023
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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