Health TrialsbyHealthPanel

Patch Study (Patch-augmented Rotator Cuff Repair)

ConditionRotator Cuff Tears
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorSpital Thurgau AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Treatment group with patch augmentationExperimental treatment 1 intervention
Group B: Comparison group without patch augmentationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rotator cuff retear rate

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

Time frame
Up to two years postoperative

Secondary outcomes

1

Complication rate (adverse event greater than grade 2)

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

Time frame
Up to two years postoperative
2

Pain levels

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

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

Healing rate

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

Time frame
6-week and 1-year exams (postoperative)
4

Range of motion

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spital Thurgau AG

Lead sponsor

Source ClinicalTrials.gov
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