Rotator Cuff TearsNCT06076902
Patch Study (Patch-augmented Rotator Cuff Repair)
A study testing Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)) and Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch in people with Rotator Cuff Tears, run by Spital Thurgau AG at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)) and Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Apr 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Spital Thurgau AG
Frauenfeld, Thurgau, 8501
Florian Hess, MD, +41 58 144 8143, florian.hess@stgag.ch
About this study
Official title: Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester 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.
Read the detailed description
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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)), Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch
- Keywords
- Rotator Cuff Repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))Device
Also called Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)
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 patchDevice
Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group with patch augmentation | Experimental | Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch Receives: 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 Receives: Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff retear rate
Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound)
Measured: Up to two years postoperative
Secondary outcomes (4)
Complication rate (adverse event greater than grade 2)
Development of postoperative complications following rotator cuff reconstruction to treat massive tear
Measured: Up to two years postoperative
Pain levels
During clinical assessments, patient reported pain levels will be measured using visual analogue scale (VAS); scale 0 (low) to 15 (high)
Measured: Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)
Healing rate
Using radiological imaging (ultrasound), healing of the rotator cuff tear will be monitored over time
Measured: 6-week and 1-year exams (postoperative)
Range of motion
Clinical assessments of healing using the range of motion will be compared over time
Measured: Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start6 Apr 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spital Thurgau AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Hess, MD, Principal investigator, Spital Thurgau AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076902
- Sponsor's protocol ID
- ProjectID 2023-00238
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT06076902
- Acronym / sponsor ID
- ProjectID 2023-00238
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator Cuff Repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Spital Thurgau AGUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group with patch augmentation | Experimental | Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch |
| Comparison group without patch augmentation | Active comparator | Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patchArthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))Also: Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)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. | Device | Treatment group with patch augmentation |
| Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patchArthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. | Device | Comparison group without patch augmentation |
Primary outcome
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)
4 secondary outcomes
Complication rate (adverse event greater than grade 2)
Time frame: Up to two years postoperative
Pain levels
Time frame: Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)
Healing rate
Time frame: 6-week and 1-year exams (postoperative)
Range of motion
Time frame: Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian Hess, MD principal investigator
Spital Thurgau AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)) and Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch in people with Rotator Cuff Tears, run by Spital Thurgau AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Hess, MD (+41 58 144 8143, florian.hess@stgag.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotator cuff retear rate (time frame: Up to two years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.