JuggerStitch post-market klinische follow-upstudie
JuggerStitch™ voor meniscusreparatie Klinische vervolgstudie na marktonderzoek
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).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Magdeburg, Duitsland, 39120
- Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
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Lyon, Frankrijk, 69008
- Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
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Tokyo, Japan, 113-8519
- Tokyo Medical and Dental University Hospital of Medicine
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Ibaraki
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Tsukuba, Ibaraki, Japan, 300-3295
- Ichihara Hospital
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28207
- OrthoCarolina
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Virginia
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Richmond, Virginia, Verenigde Staten, 23226
- OrthoVirginia, Inc.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Meniscal repair
Patients in need of meniscal repair |
Treatment of torn meniscus with JuggerStitch. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Clinical Success
Tijdsspanne: 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
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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. |
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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Adverse Events
Tijdsspanne: 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
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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. |
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
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Lysholm Knee Scoring Scale Score
Tijdsspanne: Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
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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. |
Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
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Tegner Activity Scale Score
Tijdsspanne: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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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. |
Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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International Knee Documentation Committee Subjective Knee Evaluation Form Score
Tijdsspanne: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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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. |
Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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Number of Participants by Joint Line Tenderness Test Result
Tijdsspanne: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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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. |
Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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Number of Participants by McMurray Test Result
Tijdsspanne: Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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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. |
Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Kim Blick, Zimmer Biomet
- Studie stoel: Nesma Bayrich, DDS, Zimmer Biomet
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CMG2017-14SM
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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