Rotator Cuff TearsNCT03511547
Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.
A study testing Pitch Patch and ArthroFlex in people with Rotator Cuff Tears, run by Schulthess Klinik.
Trial summary
The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Pitch Patch and ArthroFlex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rotator cuff tear > 2 cm in the sagittal plane involving the supraspinatus tendon as well as at least the superior 1/3 of the infraspinatus tendon
- Indicated for surgical reconstruction by arthroscopy
- Patient aged 60 years and over
- Consenting participation in this study by signing the Informed Consent form
Who cannot join
- Osteoarthritis (grade ≥ 2 after Samilson \& Prieto)
- Advanced fatty infiltration of the rotator cuff muscles (Goutallier grade III or IV)
- Tear of the subscapularis > Typ 1 Lafosse (partial tears of superior 1/3 of the tendon)
- Irreparable tear of the supraspinatus
- General medical contraindication to surgery
- Known hypersensitivity to the materials used
Show all 16Show fewer
- Revision operations
- Open reconstruction
- Tendon transfer necessary (latissimus dorsi or pectoralis major)
- Any disease process that would preclude accurate evaluation including:
- Systemic arthritis, rheumatoid arthritis, diabetes (insulin dependent), acute or chronic infection, abnormal bone metabolism, tumour / malignoma, psychiatric disorder
- Inadequate blood flow or neuromuscular disease in the affected arm
- Recent history of substance abuse
- Legal incompetence
- German language barrier to complete the questionnaires or
- Participation in any other medical device or medicinal product study that could influence the results of the present study
About this study
Official title: Arthroscopic Rotator Cuff Reconstruction With or Without Biologic or Synthetic Patch Augmentation in Patients Over 60 Years: a Randomized Controlled Trial
The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches.
Read the detailed description
An arthroscopic rotator cuff repair is nowadays mostly implemented in order to restore function and reduce or eliminate pain. The primary objective of this randomized controlled trial is to demonstrate, in patients 60 years or older with a large rotator cuff tear, that biological or synthetic patch augmen-tation in arthroscopic rotator cuff repair results in decreased rate of retear 24 months post-operatively compared to re-pair without patch augmentation.
- Conditions
- Rotator Cuff Tears
- Being tested
- Pitch Patch, ArthroFlex
- 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.
Pitch PatchDevice
The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a synthetic (Pitch-Patch™ [PP]) augmentation.
ArthroFlexDevice
The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a biologic patch (ArthroFlex® [AF]) augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1: Pitch-Patch | Active comparator | Reconstruction with patch augmentation using a synthetic patch Receives: Device: Pitch Patch |
| Intervention group 2: ArthroFlex | Active comparator | Reconstruction with patch augmentation using a biological human dermis patch Receives: Device: ArthroFlex |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of retear
Repair integrity will be assessed by an independent assessor on the basis of centralized MRI images.
Measured: 24 months
Secondary outcomes (9)
Pain level (NRS)
The pain level in the operated shoulder will be measured with a numeric rating scale (0=no pain, 10 = maximum pain) as part as the Constant Murley Score (CS)
Measured: 6/24 months
Range of motion (flexion, abduction, external and internal rotation)
The following active and passive range of motion parameters of the affected shoulder will be documented using a goniometer : Elevation (flexion), abduction, External rotation by 0° abduction, external-internal rotation by 90° abduction
Measured: 6/24 months
Shoulder strength in 90° abduction and in external rotation (0° abduction)
The shoulder strenght will be measured with an isobex device
Measured: 6/24 months
Constant Murley Score (CS)
The CMS is a 100-point scoring system that is divided into four subscales: pain (15 points), activities of daily living (20 points), range of motion (40 points) and strength (25 points).Pain and activities of daily living are self-reported by the patient using visual analog scales and ordinal categories. Range of motion is obtained during active painfree elevation in flexion and abduction (using a goniometer), and functional internal and external rotation of the shoulder (using ordinal scale). Strength testing was performed at 90° of abduction in the scapular plane.
Measured: 6/24 months
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured.
Measured: 6/24 months
Subjective shoulder value (SSV)
The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?"
Measured: 6/24 months
Quality of life (utilities) and general health using EQ-5D-5L
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys.
Measured: 6/24 months
Subjective improvement, expectation, satisfaction with treatment
Patients will be asked to assess their current state of health related to the operated shoulder at follow-up compared to the state before surgery. Further on A similar question will be asked regarding their perceived change in quality of life.At the 24-month follow-up questionnaire, patients will rate whether the surgical results met their expectations:
Measured: 6/24 months
Adverse events / complications
Adverse events will be analyzed according to their type and time of occurrence, severity and relation-to-implant: Local AEs within 24 months and Non-local AEs within 3 months
Measured: 3/6/24 months and intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Why it stopped: Personal reasons
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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Scheibel, Prof, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511547
- Sponsor's protocol ID
- ARCR-RCT
- Status last verified
- Apr 2018
- First submitted
- 18 Apr 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Reconstruction With or Without Biologic or Synthetic Patch Augmentation in Patients Over 60 Years: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03511547
- Acronym / sponsor ID
- ARCR-RCT
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Personal reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 30 Apr 2018 (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.
The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches.
Detailed description
An arthroscopic rotator cuff repair is nowadays mostly implemented in order to restore function and reduce or eliminate pain. The primary objective of this randomized controlled trial is to demonstrate, in patients 60 years or older with a large rotator cuff tear, that biological or synthetic patch augmen-tation in arthroscopic rotator cuff repair results in decreased rate of retear 24 months post-operatively compared to re-pair without patch augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1: Pitch-Patch | Active comparator | Device: Pitch PatchReconstruction with patch augmentation using a synthetic patch |
| Intervention group 2: ArthroFlex | Active comparator | Device: ArthroFlexReconstruction with patch augmentation using a biological human dermis patch |
| Control | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rotator cuff tear > 2 cm in the sagittal plane involving the supraspinatus tendon as well as at least the superior 1/3 of the infraspinatus tendon
- Indicated for surgical reconstruction by arthroscopy
- Patient aged 60 years and over
- Consenting participation in this study by signing the Informed Consent form
Key exclusion criteria (16 listed)
- Osteoarthritis (grade ≥ 2 after Samilson \& Prieto)
- Advanced fatty infiltration of the rotator cuff muscles (Goutallier grade III or IV)
- Tear of the subscapularis > Typ 1 Lafosse (partial tears of superior 1/3 of the tendon)
- Irreparable tear of the supraspinatus
- General medical contraindication to surgery
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 |
|---|---|---|
| Pitch PatchThe patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a synthetic (Pitch-Patch™ [PP]) augmentation. | Device | Intervention group 1: Pitch-Patch |
| ArthroFlexThe patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a biologic patch (ArthroFlex® [AF]) augmentation. | Device | Intervention group 2: ArthroFlex |
Primary outcome
Occurrence of retear
Time frame: 24 months
Repair integrity will be assessed by an independent assessor on the basis of centralized MRI images.
9 secondary outcomes
Pain level (NRS)
Time frame: 6/24 months
Range of motion (flexion, abduction, external and internal rotation)
Time frame: 6/24 months
Shoulder strength in 90° abduction and in external rotation (0° abduction)
Time frame: 6/24 months
Constant Murley Score (CS)
Time frame: 6/24 months
Oxford Shoulder Score (OSS)
Time frame: 6/24 months
Subjective shoulder value (SSV)
Time frame: 6/24 months
Quality of life (utilities) and general health using EQ-5D-5L
Time frame: 6/24 months
Subjective improvement, expectation, satisfaction with treatment
Time frame: 6/24 months
Adverse events / complications
Time frame: 3/6/24 months and intra-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Markus Scheibel, Prof principal investigator
Schulthess Klinik
Questions about this trial
What is this clinical trial studying?
A study testing Pitch Patch and ArthroFlex in people with Rotator Cuff Tears, run by Schulthess Klinik.
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 4 inclusion and 16 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: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of retear (time frame: 24 months). 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 22 Oct 2020.