Rotator Cuff Tears of the ShoulderNCT06818448
SINEFIX-2022 Comparative Phase
A study testing Rotator cuff repair with the SINEFIX and Rotator cuff repair with comparator device in people with Rotator Cuff Tears of the Shoulder, run by BAAT Medical Products B.V. at 2 sites in Germany.
Trial summary
Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears of the Shoulder
- What is being tested?
- Rotator cuff repair with the SINEFIX and Rotator cuff repair with comparator device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- 16 Sep 2025to Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient indicated for surgical repair of the rotator cuff tear according to current guidelines
- Patient aged 18 years or older
- Up to 2 cm tear size (medio-lateral) of supraspinatus, infraspinatus
- Up to 2 cm tear size (anterior-posterior) of supraspinatus, infraspinatus
Who cannot join
- Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder
- History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments
- Inflammatory arthropathies
- Subject with a contraindication/non-compliance for MRI examination
- Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule
- Pregnant and breastfeeding woman
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Kreiskrankenhaus Mechernich GmbH (KKHM)
Mechernich, 53894
Anas Malkawi, MD, +492443/17-1751, anas.malkawi@kkhm.de
Anas Malkawi, MD
- Recruiting
Orthopädisch Chirurgisches Centrum (OCC)
Tübingen, 72074
Philip Kasten, Prof. Dr., +49 (0) 7071 560 90, kasten@occ-tuebingen.de
Philip Kasten, Prof. Dr.
About this study
Official title: Pre-market Clinical Investigation Inovedis SINEFIX
Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full- thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended.
Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs.
Read more
For RCTs, treatment options include both surgical and non-surgical (conservative) procedures.
In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction.
A pilot study phase investigating the SINEFIX implant and instruments was conducted and showed adequate performance, usability and preliminary safety. Hence, the device is now being tested on a larger number of participants as part of the comparative study phase.
- Conditions
- Rotator Cuff Tears of the Shoulder
- Being tested
- Rotator cuff repair with the SINEFIX, Rotator cuff repair with comparator device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator cuff repair with the SINEFIXDevice
Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments
Rotator cuff repair with comparator deviceDevice
Treatment of rotator cuff lesions with the conventional surgical technique (comparator device)
| Study group | Role | What they receive |
|---|---|---|
| SINEFIX | Experimental | Rotator cuff repair with the SINEFIX implant, using the SINEFIX instruments Receives: Device: Rotator cuff repair with the SINEFIX |
| Comparator | Active comparator | Rotator cuff repair with the conventional surgical technique (comparator device) Receives: Device: Rotator cuff repair with comparator device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and clinical outcome after rotator cuff repair as compared with baseline
Functional and clinical outcome after rotator cuff repair will be assessed using the increase in total Constant Murley score at 1 year follow-up compared with baseline (range 0 (worst outcome) -100 (best outcome))
Measured: 1 year post operation
Secondary outcomes (12)
Surgery time
The total procedure duration will be recorded as the surgery time
Measured: Immediately post procedure
Functional and clinical outcome after rotator cuff repair
Functional and clinical outcome after rotator cuff repair will be assessed using the total Constant Murley score at 6 months, 1 and 2 years follow-up (range 0 (worst outcome) -100 (best outcome))
Measured: At 6 months, 1 and 2 years follow-up
Functional and clinical outcome after rotator cuff repair as compared with baseline
Functional and clinical outcome after rotator cuff repair will be assessed using the increase in total Constant Murley score at 6 months and 2 years compared with baseline (range 0 (worst outcome) - 100 (best outcome))
Measured: At 6 months and 2 years follow-up
Shoulder function after rotator cuff repair (subjective evaluation)
Shoulder function after rotator cuff repair will be assessed through the Subjective Shoulder Value (SSV) which ranges from 0% to 100% (best outcome)
Measured: At 10 weeks, 6, 12, and 24 months
Shoulder function after rotator cuff repair (physical examination-active external rotation)
Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active external rotation (range 0°-90°)
Measured: At 10 weeks, 6, 12, and 24 months
Shoulder function after rotator cuff repair (physical examination-active anteversion)
Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active anteversion (0°-180°)
Measured: At 10 weeks, 6, 12, and 24 months
Healing integrity
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/ no)
Measured: At 6, 12, and 24 months
Re-tear rate
Re-tear rate will be assessed with MRI
Measured: At 6, 12, and 24 months
Dislocation of the implant
Presence of dislocation will be assessed with MRI (yes/no)
Measured: At 6, 12, and 24 months
Bursitis
Presence of bursitis will be assessed with MRI (yes/no)
Measured: At 6, 12, and 24 months
Complications
Complications will be systematically reported. Complications of particular interest for the purpose of the study are neurological problems, bleeding, impaired wound healing, infection and frozen shoulder.
Measured: During the follow up time (up to 24 months)
Patient satisfaction
The patient will be asked to rate his/her satisfaction with outcome of the surgical repair (0=completely unsatisfied, 1=unsatisfied, 2=satisfied, 3=completely satisfied)
Measured: At 10 weeks, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start16 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tears of the ShoulderStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BAAT Medical Products B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818448
- Sponsor's protocol ID
- SINEFIX-2022 Comparative Phase
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-market Clinical Investigation Inovedis SINEFIX
- ClinicalTrials.gov ID
- NCT06818448
- Acronym / sponsor ID
- SINEFIX-2022 Comparative Phase
- Conditions
- Rotator Cuff Tears of the Shoulder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BAAT Medical Products B.V.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Feb 2025 (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.
Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full- thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended.
Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs.
For RCTs, treatment options include both surgical and non-surgical (conservative) procedures.
In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction.
A pilot study phase investigating the SINEFIX implant and instruments was conducted and showed adequate performance, usability and preliminary safety. Hence, the device is now being tested on a larger number of participants as part of the comparative study phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SINEFIX | Experimental | Device: Rotator cuff repair with the SINEFIXRotator cuff repair with the SINEFIX implant, using the SINEFIX instruments |
| Comparator | Active comparator | Device: Rotator cuff repair with comparator deviceRotator cuff repair with the conventional surgical technique (comparator device) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient indicated for surgical repair of the rotator cuff tear according to current guidelines
- Patient aged 18 years or older
- Up to 2 cm tear size (medio-lateral) of supraspinatus, infraspinatus
- Up to 2 cm tear size (anterior-posterior) of supraspinatus, infraspinatus
Key exclusion criteria (6 listed)
- Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder
- History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments
- Inflammatory arthropathies
- Subject with a contraindication/non-compliance for MRI examination
- Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule
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 |
|---|---|---|
| Rotator cuff repair with the SINEFIXTreatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments | Device | SINEFIX |
| Rotator cuff repair with comparator deviceTreatment of rotator cuff lesions with the conventional surgical technique (comparator device) | Device | Comparator |
Primary outcome
Functional and clinical outcome after rotator cuff repair as compared with baseline
Time frame: 1 year post operation
Functional and clinical outcome after rotator cuff repair will be assessed using the increase in total Constant Murley score at 1 year follow-up compared with baseline (range 0 (worst outcome) -100 (best outcome))
12 secondary outcomes
Surgery time
Time frame: Immediately post procedure
Functional and clinical outcome after rotator cuff repair
Time frame: At 6 months, 1 and 2 years follow-up
Functional and clinical outcome after rotator cuff repair as compared with baseline
Time frame: At 6 months and 2 years follow-up
Shoulder function after rotator cuff repair (subjective evaluation)
Time frame: At 10 weeks, 6, 12, and 24 months
Shoulder function after rotator cuff repair (physical examination-active external rotation)
Time frame: At 10 weeks, 6, 12, and 24 months
Shoulder function after rotator cuff repair (physical examination-active anteversion)
Time frame: At 10 weeks, 6, 12, and 24 months
Healing integrity
Time frame: At 6, 12, and 24 months
Re-tear rate
Time frame: At 6, 12, and 24 months
Dislocation of the implant
Time frame: At 6, 12, and 24 months
Bursitis
Time frame: At 6, 12, and 24 months
Complications
Time frame: During the follow up time (up to 24 months)
Patient satisfaction
Time frame: At 10 weeks, 6, 12, 24 months
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 3 Jun 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator cuff repair with the SINEFIX and Rotator cuff repair with comparator device in people with Rotator Cuff Tears of the Shoulder, run by BAAT Medical Products B.V. at 2 sites in Germany.
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 6 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Tess Van Dam (+31-(0)88-5656600, tess@baatmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional and clinical outcome after rotator cuff repair as compared with baseline (time frame: 1 year post operation). 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 3 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.