Meniscus Tear, TibialNCT04228367
JuggerStitch Post Market Clinical Follow-up Study
A study testing JuggerStitch Meniscal Repair Device in people with Meniscus Tear, Tibial and Meniscus Lesion, run by Zimmer Biomet at 6 sites in 4 countries.
Trial summary
This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Tear, Tibial, Meniscus Lesion
- What is being tested?
- JuggerStitch Meniscal Repair Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 25 Sep 2020to 31 May 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
- Older than 18 years and skeletally mature;
- Willing and able to comply with the study procedures;
- Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
- Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.
Who cannot join
- Meniscal tears in the avascular zone of meniscus;
- Meniscal tears not suitable for repair because of the degree of damage(marked irregularity and complex tearing) to the meniscus body including degenerative, radial, horizontal cleavage and flap tears;
- Presence of active infection;
- If female, subject is pregnant;
- Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
- The subject is unwilling or unable to give consent or to comply with the follow-up program;
- Subject meets any contraindications of the appropriate Instruction for Use.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States2 sites
OrthoCarolina
Charlotte, North Carolina, 28207
OrthoVirginia, Inc.
Richmond, Virginia, 23226
Japan2 sites
Tokyo Medical and Dental University Hospital of Medicine
Tokyo, 113-8519
Ichihara Hospital
Tsukuba, Ibaraki, 300-3295
France1 site
Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
Lyon, 69008
Germany1 site
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120
About this study
Official title: JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study
This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).
Read the detailed description
This study is a post-market follow-up study to fulfil the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12/2 and the Medical Devices Regulation (MDR 2017/745). The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (IFU).
The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair Device. The primary endpoint of this study is defined by the absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.
- Conditions
- Meniscus Tear, Tibial, Meniscus Lesion
- Being tested
- JuggerStitch Meniscal Repair Device
- Medical subject headings
- Tibial Meniscus Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuggerStitch Meniscal Repair DeviceDevice
Treatment of torn meniscus with JuggerStitch.
| Study group | Role | What they receive |
|---|---|---|
| Meniscal repair | Experimental | Patients in need of meniscal repair Receives: Device: JuggerStitch Meniscal Repair Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
The absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at 1 year. Clinical success was defined as the absence of reoperation of the index knee due to a meniscal tear from the date of surgery through the participant's last available follow-up. All participants included in the analysis had at least 1 year of follow-up, and follow-up beyond 1 year was included when available.
Measured: From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years
Secondary outcomes (6)
Number of Adverse Events
The total number of adverse events reported from the date of surgery through each participant's last available follow-up was assessed to evaluate the safety of the JuggerStitch Meniscal Repair Device. Events were included regardless of seriousness or assessed relationship to the device, instrumentation, or procedure.
Measured: From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years
Lysholm Knee Scoring Scale Score
The Lysholm Knee Scoring Scale assesses knee symptoms and function based on pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. The total score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms.
Measured: Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
Tegner Activity Scale Score
The Tegner Activity Scale assesses participation in work and sports activities. Scores range from 0 to 10, where 0 indicates sick leave or disability because of knee problems and 10 indicates participation in competitive elite sports. Higher scores indicate a higher level of physical activity.
Measured: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
International Knee Documentation Committee Subjective Knee Evaluation Form Score
The International Knee Documentation Committee Subjective Knee Evaluation Form assesses knee symptoms, function, and ability to participate in sports activities. The total score ranges from 0 to 100, with higher scores indicating fewer symptoms, better knee function, and a better outcome.
Measured: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Number of Participants by Joint Line Tenderness Test Result
The Joint Line Tenderness Test was performed during clinical examination by palpating the medial and lateral joint lines of the operated knee. The test was considered positive when palpation elicited joint line pain or tenderness and negative when no joint line pain or tenderness was elicited. Results are reported as the number of participants with positive and negative findings at each assessment.
Measured: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Number of Participants by McMurray Test Result
The McMurray Test was performed during the clinical examination of the operated knee using knee flexion and extension with tibial rotation and applied varus or valgus stress. The test was considered positive when pain, snapping, an audible or palpable click, or locking suggestive of meniscal pathology was elicited. The test was considered negative when none of these findings was present. Results are reported as the number of participants with positive and negative test findings at each assessment.
Measured: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start25 Sep 2020
- Primary completion30 Apr 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meniscus Tear, TibialStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nesma Bayrich, DDS, Study chair, Zimmer BiometKim Blick, Study chair, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228367
- Sponsor's protocol ID
- CMG2017-14SM
- Status last verified
- Jun 2026
- First submitted
- 10 Jan 2020
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT04228367
- Acronym / sponsor ID
- CMG2017-14SM
- Conditions
- Meniscus Tear, Tibial, Meniscus Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Posted 24 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).
Detailed description
This study is a post-market follow-up study to fulfil the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12/2 and the Medical Devices Regulation (MDR 2017/745). The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (IFU).
The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair Device. The primary endpoint of this study is defined by the absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meniscal repair | Experimental | Device: JuggerStitch Meniscal Repair DevicePatients in need of meniscal repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
- Older than 18 years and skeletally mature;
- Willing and able to comply with the study procedures;
- Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
- Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.
Key exclusion criteria (7 listed)
- Meniscal tears in the avascular zone of meniscus;
- Meniscal tears not suitable for repair because of the degree of damage(marked irregularity and complex tearing) to the meniscus body including degenerative, radial, horizontal cleavage and flap tears;
- Presence of active infection;
- If female, subject is pregnant;
- Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
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 |
|---|---|---|
| JuggerStitch Meniscal Repair DeviceTreatment of torn meniscus with JuggerStitch. | Device | Meniscal repair |
Primary outcome
Clinical Success
Time frame: From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years
The absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at 1 year. Clinical success was defined as the absence of reoperation of the index knee due to a meniscal tear from the date of surgery through the participant's last available follow-up. All participants included in the analysis had at least 1 year of follow-up, and follow-up beyond 1 year was included when available.
6 secondary outcomes
Number of Adverse Events
Time frame: From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years
Lysholm Knee Scoring Scale Score
Time frame: Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
Tegner Activity Scale Score
Time frame: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
International Knee Documentation Committee Subjective Knee Evaluation Form Score
Time frame: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Number of Participants by Joint Line Tenderness Test Result
Time frame: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Number of Participants by McMurray Test Result
Time frame: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Nesma Bayrich, DDS study chair
Zimmer Biomet
Kim Blick study chair
Zimmer Biomet
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JuggerStitch Meniscal Repair Device in people with Meniscus Tear, Tibial and Meniscus Lesion, run by Zimmer Biomet at 6 sites in 4 countries.
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: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Japan, France, 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?
Yes. Results are posted in the registry (first posted 24 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Success (time frame: From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years). 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 24 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.