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

E

eMKa MED Medical Center

Status

Unknown

Conditions

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

Treatments

Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix
Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch

Study type

Interventional

Funder types

Other

Identifiers

NCT05318118
KB-98/2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix
Active Comparator group
Treatment:
Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix
Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch
Active Comparator group
Treatment:
Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch

Trial contacts and locations

1

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Central trial contact

Kacper Kentel, master's degree; Maciej Kentel, MD PhD

Data sourced from clinicaltrials.gov

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