Clinical trial NCT04228367: JuggerStitch Post Market Clinical Follow-up Study
Official title: JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscus Tear, Tibial
Meniscus Lesion
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2020-01-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Clinical Success
timeFrame: 1 year
Secondary outcomes:
measure: Monitoring of Adverse Events to confirm safety of the meniscal repair device
timeFrame: 1 year
Other outcomes:
measure: Lysholm Knee Scoring Scale
timeFrame: Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
measure: Tegner Activity Level Scale
timeFrame: Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
measure: International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
timeFrame: Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Richmond
country: United States
facility: OrthoVirginia, Inc.
state: Virginia
city: Lyon
country: France
facility: Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
city: Magdeburg
country: Germany
facility: Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
city: Tsukuba-shi
country: Japan
facility: Ichihara Hospital
state: Ibaraki-ken
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital of Medicine
Study officials:
affiliation: Zimmer Biomet
name: Elliott Goff, PhD
role: STUDY_CHAIR
affiliation: Zimmer Biomet
name: Kim Blick
role: STUDY_CHAIR
References: