Rotator Cuff Tears (RCTs)NCT05721560
SINEFIX-2022 Pilot Phase
A study testing Rotator cuff repair with the SINEFIX in people with Rotator Cuff Tears (RCTs), run by BAAT Medical Products B.V. at 1 site 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 (RCTs)
- What is being tested?
- Rotator cuff repair with the SINEFIX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- 12 Sep 2023to 16 Jun 2026
- 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 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 of supraspinatus, infraspinatus (medio-lateral)
- Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior)
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
1 site in 1 country.
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.
- Conditions
- Rotator Cuff Tears (RCTs)
- Being tested
- Rotator cuff repair with the SINEFIX
- 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.
Rotator cuff repair with the SINEFIXDevice
Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing integrity
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)
Measured: 3 months post operation
Re-tear rate
Re-tear rate will be assessed with MRI
Measured: 3 months post operation
Dislocation of the implant
Presence of dislocation of the implant will be assessed with MRI (yes/no)
Measured: 3 months post operation
Bursitis
Presence of bursitis will be assessed with MRI (yes/no)
Measured: 3 months post operation
Secondary outcomes (14)
Surgery time
The total procedure duration will be recorded as the surgery time
Measured: Immediately post procedure
Usability and workflow assessment
Usability and workflow assessment will be evaluated after each intervention through a practitioner's questionnaire covering different aspects of the implant and instruments
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, which ranges from 0 (worst outcome) to 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 change of the total Constant Murley score (range 0-100) as compared to baseline
Measured: At 6 months, 1 and 2 years follow-up
Shoulder function after rotator cuff repair (subjective evaluation)
Shoulder function after rotator cuff repair (subjective evaluation) 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
Safety endpoint
Safety of the device will be evaluated by systematically reporting device deficiencies (DDs), adverse events (AEs) and serious adverse events (SAEs) and by monitoring the frequency and incidence of these events
Measured: During the intervention and the follow up time (up to 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 2023
- Study start12 Sep 2023
- Primary completion23 Jul 2024
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tears (RCTs)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot phase: single-arm prospective non-comparative single-centre study phase
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
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
- NCT05721560
- Sponsor's protocol ID
- SINEFIX-2022
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2023
- Last updated
- 5 Oct 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 5 Oct 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
- NCT05721560
- Acronym / sponsor ID
- SINEFIX-2022
- Conditions
- Rotator Cuff Tears (RCTs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- BAAT Medical Products B.V.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 10 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot phase: single-arm prospective non-comparative single-centre study phase
| Arm | Type | Receives |
|---|---|---|
| SINEFIX | Experimental | Device: Rotator cuff repair with the SINEFIXRotator cuff repair with the SINEFIX implant, using the SINEFIX instruments |
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 of supraspinatus, infraspinatus (medio-lateral)
- Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior)
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 |
Primary outcome
Healing integrity
Time frame: 3 months post operation
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)
Re-tear rate
Time frame: 3 months post operation
Re-tear rate will be assessed with MRI
Dislocation of the implant
Time frame: 3 months post operation
Presence of dislocation of the implant will be assessed with MRI (yes/no)
Bursitis
Time frame: 3 months post operation
Presence of bursitis will be assessed with MRI (yes/no)
14 secondary outcomes
Surgery time
Time frame: Immediately post procedure
Usability and workflow assessment
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, 1 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
Safety endpoint
Time frame: During the intervention and the follow up time (up to 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tears (RCTs)
Not yet recruitingObservational study
Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise
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Platelet-Rich Plasma for Partial Rotator Cuff Tears
Partial Supraspinatus Tear, Rotator Cuff Tears (RCTs)
Recruiting
RSA Vs RCR for Massive RCTs
Rotator Cuff Tears
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 in people with Rotator Cuff Tears (RCTs), run by BAAT Medical Products B.V. at 1 site 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: finished, as of the sponsor's last update on 5 Oct 2026. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Healing integrity (time frame: 3 months post operation). The study lists 4 primary outcomes in all. 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 5 Oct 2026.