Comparison of the Results of Arthroscopic Suturing of the Medial Meniscus Using the Fast Fix and FiberStitch Systems

NCT ID: NCT05318118

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2022-09-01

Brief Summary

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Clinical and comparative evaluation of the treatment results of arthroscopic reconstruction of the medial meniscus of the knee joint using the Fast Fix and FiberStitch systems.

Detailed Description

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The main goal of the project is to evaluate the results of medial meniscus traumatic injury suturing. Further (detailed) objectives are: to compare the results obtained in the study groups of suturing the medial meniscus with the use of two systems: Fast Fix (smith \& nephew) and Fiber Stitch (arthrex). The results refering to the operated limb will be compared in both groups between themselves and furthermore with the results of clinical and biomechanical studies on non-operated limbs.

Conditions

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Meniscus; Detachment, Current Injury Detachment Medial Mensical Tear Medial Meniscus Knee Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The results refering to the operated limb will be compared in both groups between themselves and furthermore with the results of clinical and biomechanical studies on non-operated limbs.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix

Group Type ACTIVE_COMPARATOR

Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix

Intervention Type PROCEDURE

Arthroscopic reconstruction of damaged Medial Meniscus using Fast-Fix (Smith \& Nephew) implant.

Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch

Group Type ACTIVE_COMPARATOR

Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch

Intervention Type PROCEDURE

Arthroscopic reconstruction of damaged Medial Meniscus using Fiber-Stitch (Arthrex) implant

Interventions

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Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix

Arthroscopic reconstruction of damaged Medial Meniscus using Fast-Fix (Smith \& Nephew) implant.

Intervention Type PROCEDURE

Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch

Arthroscopic reconstruction of damaged Medial Meniscus using Fiber-Stitch (Arthrex) implant

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Isolated MM damage.
* Operation performed only in arthroscopy technique.
* No any knee intervention earlier.
* No other pathology in the anatomical area.
* Patient informed consent to participate in research

Exclusion Criteria

* Age under 18 years old or above 35 years old.
* Any knee intervention performed earlier.
* Any other pathology in the anatomical area identified during preoperative diagnostics.
* Any damage in the area of the second knee joint.
* Failure complying the same treatment protocol rigor.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role collaborator

eMKa MED Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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eMKa MED Medical Center

Wroclaw, Dolnośląsk, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Maciej Kentel, MD PhD

Role: CONTACT

+48518744908

Kacper Kentel, master's degree

Role: CONTACT

+48695263711

Facility Contacts

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Maciej Kentel, MD

Role: primary

+48518744908

Kacper Kentel, master's degree

Role: backup

+48695263711

Other Identifiers

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KB-98/2021

Identifier Type: -

Identifier Source: org_study_id

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