CompletedNCT04228367Updated Sep 24, 2026Results posted

JuggerStitch Post Market Clinical Follow-up Study

An interventional study of JuggerStitch Meniscal Repair Device in Meniscus Tear, Tibial and Meniscus Lesion, sponsored by Zimmer Biomet. Completed at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 103
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Meniscus Tear, Tibial
Meniscus Lesion

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 103 participants (actual)

Study arms

Experimental
Meniscal repair
Patients in need of meniscal repair
Device: JuggerStitch Meniscal Repair Device

Interventions

DeviceJuggerStitch Meniscal Repair Device
Treatment of torn meniscus with JuggerStitch.

What researchers measure

Primary outcomes

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.
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

Secondary outcomes

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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively

Results

Posted Sep 24, 2026

Limitations and caveats

This was a post-market clinical follow-up study with a single-arm design and no control group. Few participants did not complete the 1-year follow-up; therefore, outcome analyses were based on available data. Race and ethnicity data were not collected.

Participant flow

Participant flow — Overall Study
Milestone	Meniscal Repair
Started	103
Completed	103
Not completed	0

Outcome measures

PrimaryClinical 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.

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
Reported as:: Count of participants · Participants

Clinical Success
Participants	Meniscal Repair
Clinical Success	101

SecondaryNumber 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.

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
Reported as:: Number · Adverse Events

Number of Adverse Events
Adverse Events	Meniscal Repair
Number of Adverse Events	10

SecondaryLysholm 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.

Time frame:: Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
Reported as:: Mean · units on a scale

Lysholm Knee Scoring Scale Score
units on a scale	Meniscal Repair
Preoperative	56.0 ± 22.0
6 Weeks Postoperatively	63.3 ± 19.9
6 Months Postoperatively	85.0 ± 16.2
1 Year Postoperatively	89.0 ± 12.5

SecondaryTegner 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.

Time frame:: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Reported as:: Mean · units on a scale

Tegner Activity Scale Score
units on a scale	Meniscal Repair
Preoperative	2.6 ± 1.4
6 Weeks Postoperatively	2.1 ± 1.0
6 Months Postoperatively	4.0 ± 1.6
1 Year Postoperatively	5.4 ± 1.9

SecondaryInternational 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.

Time frame:: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Reported as:: Mean · units on a scale

International Knee Documentation Committee Subjective Knee Evaluation Form Score
units on a scale	Meniscal Repair
Preoperative	46.3 ± 13.0
6 Week Postoperative	39.1 ± 10.6
6 Months Postoperative	60.0 ± 9.8
1 Year Postoperative	66.0 ± 10.1

SecondaryNumber 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.

Time frame:: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Reported as:: Count of participants · Participants

Number of Participants by Joint Line Tenderness Test Result
Participants	Meniscal Repair
Preoperative Negative Outcome	41
Preoprative Positive Outcome	54
6 Week Negative Outcome	54
6 Week Positive Outcome	38
6 Months Negative Outcome	63
6 Months Positive Outcome	17
1 Year Negative Outcome	70
1 Year Positive Outcome	12

SecondaryNumber 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.

Time frame:: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
Reported as:: Count of participants · Participants

Number of Participants by McMurray Test Result
Participants	Meniscal Repair
Preoperative — Negative Outcome	46
Preoperative — Positive Outcome	48
6 Weeks Postoperative — Negative Outcome	79
6 Weeks Postoperative — Positive Outcome	11
6 Month Postoperative — Negative Outcome	71
6 Month Postoperative — Positive Outcome	9
1 Year Postoperative — Negative Outcome	78
1 Year Postoperative — Positive Outcome	4

Adverse events

Collected over From the date of surgery through the participant's last available follow-up; all participants had at least 1 year of follow-up, and follow-up continued beyond 1 year where available. The mean follow-up duration was 3.2 years.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Meniscal Repair	0/103 (0%)	3/103 (2.9%)	7/103 (6.8%)

Most frequent serious events

Most frequent serious events
Event	Meniscal Repair
Meniscal injuryMusculoskeletal and connective tissue disorders	1/103
Ligament injuryMusculoskeletal and connective tissue disorders	1/103
Device dislocationInjury, poisoning and procedural complications	1/103

Most frequent other events

Most frequent other events
Event	Meniscal Repair
COVID-19Infections and infestations	1/103
Implant site inflammationGeneral disorders	1/103
Muscle ruptureMusculoskeletal and connective tissue disorders	1/103
Meniscal injuryMusculoskeletal and connective tissue disorders	1/103
ChondromalaciaMusculoskeletal and connective tissue disorders	1/103
Surgical site infectionInfections and infestations	1/103
Joint stiffnessMusculoskeletal and connective tissue disorders	1/103

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Meniscal Repair
Mean	37.0 ± 15.5

Sex: Female, Male
Sex: Female, Male(Participants)	Meniscal Repair
Female	30
Male	73

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Meniscal Repair

Region of Enrollment
Region of Enrollment(participants)	Meniscal Repair
United States	29
Japan	53
France	13
Germany	8

Body Mass Index of participants
Body Mass Index of participants(kilograms per square meter)	Meniscal Repair
Mean	24.2 ± 3.2

Study locations

6 sites

OrthoCarolina
Charlotte, North Carolina 28207, United States
OrthoVirginia, Inc.
Richmond, Virginia 23226, United States
Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
Lyon, 69008, France
Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120, Germany
Ichihara Hospital
Tsukuba, Ibaraki 300-3295, Japan
Tokyo Medical and Dental University Hospital of Medicine
Tokyo, 113-8519, Japan

References and documents

Study documents

Protocol and statistical analysis plan · Mar 7, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT04228367
Lead sponsor: Zimmer Biomet
Responsible party: Sponsor
First posted: Jan 14, 2020
Start date: Sep 25, 2020
Primary completion: Apr 30, 2026
Completion: May 31, 2026
Results posted: Sep 24, 2026
Last update: Sep 24, 2026

Study contacts

Nesma Bayrich, DDS

study chair · Zimmer Biomet

Kim Blick

study chair · Zimmer Biomet

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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