Collagen for Treatment of Musculoskeletal Injuries

NCT06331741 | Recruiting DMC

• 1 other identifier: 0403
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

anterior cruciate ligament; hallux rigidus; ACL reconstruction; collagen membrane; collagen matrix

Outcome Measures

Primary Outcomes (6)

• The International Knee Documentation Committee score

  Change in the score of the Form for registering the results of the knee joint examination of the The International Knee Documentation Committee (IKDC) for ACL groups values: min - 0 points (0%); max - 87 points (100%) The higher score means better outcome

  1,5 and 6 months postoperatively

• The Knee injury and Osteoarthritis Outcome Score

  Change in the score of the Knee injury and Osteoarthritis Outcome Score (KOOS) for ACL groups values: min - 0%; max - 100% The higher score means better outcome

  1,5 and 6 months postoperatively

• Modified Lysholm scale

  Change in the score of the Modified Lysholm scale for ACL groups values: min - 0%; max - 100% The higher score means better outcome

  1,5 and 12 months postoperatively

• Anterior Cruciate Ligament OsteoArthritis Score

  Assessment of the condition of the transplant based on the results of control MRI data measured on Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS) for ACL groups values: min - 0 points; max - 3 points The higher score means worse outcome

  6 months postoperatively

• American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score

  American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score (AOFAS) for Hallux Rigidus group values: min - 0 points (0%); max - 100 points (100%) The higher score means better outcome

  2, 4 and 8 weeks postoperatively

• 36-Item Short Form Survey

  36-Item Short Form Survey (SF-36) for Hallux Rigidus group values: min - (0%); max - (100%) The higher score means better outcome

  2, 4 and 8 weeks postoperatively

Study Arms (3)

The 1st group

OTHER

ACL reconstruction + collagen membrane

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

The 2nd group

OTHER

ACL reconstruction (control)

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

The 3rd group

OTHER

Hallux Rigidus + collagen membrane

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

Interventions

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

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

The 1st group

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

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

The 2nd group

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

Arthroplasty with consequent collagen membrane implantation

The 3rd group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• For ACL reconstruction groups:
• Type of damage (rupture of the anterior cruciate ligament (complete or partial);
• Availability of an informed consent form signed and dated by the patient.
• The patient's understanding of the strict requirements of the protocol, rehabilitation program and follow-up program and the desire to follow them.
• The patient's consent to the use of the following drugs: nonsteroidal anti-inflammatory drugs (NSAIDs) (according to indications); antibiotics; anticoagulants.
• For collagen membrane of the first toe:
• The type of degenerative disease of the first metatarsophalangeal joint is Hallux rigidus of stage 3-4.
• Availability of an informed consent form signed and dated by the patient.
• The patient's understanding of the strict requirements of the protocol, rehabilitation program and follow-up program and the desire to follow them.
• The patient's consent to the use of the following drugs: nonsteroidal anti-inflammatory drugs (NSAIDs) (according to indications); antibiotics; anticoagulants
• Abuse of alcohol or narcotic substances (medicines).
• Any clinically significant or symptomatic vascular or neurological disease of the lower extremities.
• The presence of rheumatoid arthritis, parainfectious or infectious arthritis and the condition after the listed diseases, as well as the following diseases in the area of the damaged knee joint: septic arthritis, inflammatory joint disease, recurrent pseudopodagra, Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson-Konovalov disease, primary osteochondromatosis, hereditary diseases, mutation of collagen genes.
• Pregnancy and planned pregnancy (inability to perform MRI), lactation period.
• Obesity (body mass index \> 30 kg/m2).

You may not qualify if:

• The patient's refusal to participate in the study;
• The development of an allergic reaction to the product;
• Loss of contact with the patient for further observation;
• The decision of the research physician to terminate the patient's participation in the study prematurely if, in the opinion of the researcher, the patient cannot continue further participation in the study for any reason.
• Significant protocol violations that may affect patient safety and/or the integrity of the study data (in consultation with the medical monitor).

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Hallux Rigidus

Interventions

Anterior Cruciate Ligament Reconstruction; Control Groups

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Alexey V Lychagin, MD, PhD

  IM Sechenov University

  STUDY CHAIR

Central Study Contacts

Marina M Lipina, MD, PhD

CONTACT

+79253122096; marina.lipina@icloud.com

Bogdan D Raikov

CONTACT

+79859599178; raykov_b_d@student.sechenov.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Main group for ACL: 5 patients with ACL injury, who undergo ACL reconstruction with collagen membrane augmentation; Reference group for ACL: 5 patients with ACL injury, who undergo ACL reconstruction without collagen membrane augmentation; Main group for HR (Hallux Rigidus): 5 patients with Hallux Rigidus, who undergo resection arthroplasty with introduction of collagen membrane Reference group: none

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 26, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

RU (1)