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Collagen for Treatment of Musculoskeletal Injuries

NCT06331741 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-03-26

No results posted yet for this study

Summary

The purpose of the study:

Evaluation of the clinical efficacy and safety of the use of collagen matrix/membrane in the surgical treatment of the consequences of injuries and diseases of the musculoskeletal system (anterior cruciate ligament tears, rigid first toe) by using IKDC, KOOS, ACLOAS, VAS, AOFAS, SF-36 scales

Conditions

  • Anterior Cruciate Ligament Injuries
  • Hallux Rigidus

Interventions

PROCEDURE

Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane

Wrapping graft (tendon of the long fibular muscle) with collagen membrane before implantation

PROCEDURE

Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group)

Implantation of the native graft (tendon of the long fibular muscle) without any augmentation method

PROCEDURE

Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity

Arthroplasty with consequent collagen membrane implantation

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Alexey V Lychagin, MD, PhD · IM Sechenov University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-03-01
Completion
2026-03-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06331741 on ClinicalTrials.gov