Anterior Cruciate Ligament InjuriesNCT06331741
Collagen for Treatment of Musculoskeletal Injuries
A study testing Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane and Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity in people with Anterior Cruciate Ligament Injuries and Hallux Rigidus, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Hallux Rigidus
- What is being tested?
- Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane and Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 22Show fewer
- 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
- Non-inclusion criteria:
- 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).
- Uncontrolled diabetes mellitus.
- Significant cardiovascular diseases currently or within 12 months prior to screening, including: chronic heart failure of class III or IV (according to the classification of the New York Cardiological Association), severe arrhythmia requiring treatment with antiarrhythmic drugs of classes Ia, Ib, Ic or III, unstable angina pectoris, myocardial infarction, heart and coronary surgery blood vessels, significant diseases of the heart valves, uncontrolled arterial hypertension with systolic blood pressure > 180 mmHg and diastolic blood pressure > 110 mmHg, pulmonary embolism or deep vein thrombosis;
- Significant thyroid dysfunction in the decompensation stage;
- Any uncontrolled concomitant somatic disease, including through a stable therapy regimen;
- Nephrotic syndrome, moderate to severe chronic renal failure, or significant kidney disease with creatinine levels > 1.5 mg/dl (132 mmol/l) in men and > 1.4 mg/dl (123 mmol/l) in women or glomerular filtration rate (GFR) < 60 ml/min;
- Current diagnosis of osteomyelitis and (or) infection with human immunodeficiency virus (HIV-1, HIV-2) and (or) hepatitis C virus (HCV) and (or) hepatitis B virus (HBV) and (or) syphilis. An increase in AST (aspartate transaminase), ALT (alanine transaminase) or alkaline phosphatase of serum ≥ 2.5 times from the upper limit of the norm; an increase in the level of total bilirubin ≥ 2 times from the upper limit of the norm;
Who cannot join
- 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.
- Inclusion in the study in violation of the inclusion/non-inclusion criteria.
- Significant protocol violations that may affect patient safety and/or the integrity of the study data (in consultation with the medical monitor).
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
Moscow, 119991
Marina M Lipina, MD, PhD, +79253122096, marina.lipina@icloud.com
About this study
Official title: Application of Collagen in Treatment of the Consequences of Injuries and Diseases of the Musculoskeletal System
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
Read the detailed description
Application of Collagen in Treatment of the Consequences of Injuries and Diseases of the Musculoskeletal System
Indications:
- Damage to the anterior cruciate ligament (ACL) of the knee joint
- Rigid first toe
Research centers:
University Clinical Hospital No. 1 of the First Sechenov Moscow State Medical University (Sechenov University)
The product under study:
The collagen membrane
Specifications:
-The product is a membrane made of type 1 collagen obtained from the ligaments of cattle. Chemically cross-linked with glutaraldehyde. The size of the membrane is 15x4x0.3 cm in dry form (can be adjusted depending on the patient's need).
Product shape: tape (medical device) Composition: type 1 collagen Packaging: in a sterilization bag Transportation: in a dry place, protected from light, at a temperature of 10 to 30 °C.
Shelf life: 2 years Storage: in a dry place, protected from light, at a temperature of 10 to 30 °C. Purpose: for implantation Storage conditions of the product: in a dry place, protected from light, at a temperature from 10 to 30 °C. Soak in saline solution for 10 minutes before use.
Sterilization: Steripak electron beam sterilization Manufacturer: Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Research objectives:
Tasks for the reconstruction of the ACL using a collagen membrane:
- Change in the score of the Form for registering the results of the knee joint examination of the International Knee Documentation Committee (IKDC);
- Change in the score of the Knee injury and Osteoarthritis Outcome Score (KOOS) relative to the baseline level;
- Change in the score of the Modified Lysholm scale relative to the initial level;
- Assessment of the condition of the transplant based on the results of control MRI data, measured on Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS)
Tasks for the application of collagen spacer of the first metatarsophalangeal joint:
- Formation of clinical groups of patients with 3-4 stages of Hallux rigidus.
- The development of personalized collagen, the formation of a membrane of the required size
- Formation of a unified protocol of the operational manual
- Development of a program of postoperative orthopedic regimen and rehabilitation
Assessment of the formation of syndesmosis by using instrumental research methods
Safety assessment parameters:
The frequency of adverse events and serious adverse events according to subjective complaints, physical examination, vital signs, ECG (Electrocardiography) and laboratory tests against the background of treatment using the technique of collagen membrane transplantation
The study population:
For the reconstruction of the anterior cruciate ligament using a collagen membrane:
men and women from 18 to 60 years old, with partial or complete damage to the anterior cruciate ligament, who will undergo autograft surgery, will be included in the work
For the collagen spacer of the first toe:
men and women from 18 to 60 years old, with 3-4 stages of Hallux rigidus, who will undergo resection arthroplasty with the introduction of a biocompatible collagen spacer into the joint cavity, will be included in the work
Number of patients:
10 patients with ACL damage 5 patients with a rigid first toe
Duration of the study:
For each patient - 12 months.
Research methodology:
Design for the reconstruction of the ACL using a collagen membrane:
The design involves the study of the medical device in experimental treatment groups in comparison with the control group.
The study group will initially include 5 patients. As a reference group, the results of treatment of 5 patients with ACL reconstruction by autograft.
Design for the collagen spacer of the first toe:
The study group will initially include 5 patients.
Description of the work stages:
For ACL reconstruction using a collagen membrane:
Screening:
- Procedure for obtaining informed consent;
- Collection of demographic data, medical history; registration of previous surgical interventions on the knee joint;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of height, body weight, body mass index (BMI) (growth is estimated once per study - at screening);
- Physical examination;
- Evaluation of MRI of the knee joint (ACLOAS);
- Registration of the previous/concomitant therapy;
- Registration of pain therapy;
- Assessment of compliance with the inclusion/non-inclusion criteria;
For patients who meet the preliminary inclusion criteria and do not meet any of the criteria for non-inclusion in the screening, the date and time of arthroscopy will be assigned.
The researcher gives the patient:
- Patient information sheet and informed consent form;
- Patient's card;
- Rehabilitation program.
Hospitalization:
Day 1
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of body weight, BMI;
- Physical examination;
- Patients will be assessed according to the following scales: the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC), assessment on the Modified Lysholm Scale
- Assessment of compliance with the inclusion/non-inclusion criteria;
- Assessment of exclusion criteria;
Day 2 Surgical treatment: ligament reconstruction. After surgery, adverse events, concomitant therapy, pain therapy, and vital signs will be re-evaluated.
Day 3-7 (Discharge)
- Assessment of adverse events, exclusion criteria, concomitant therapy, pain therapy;
- assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Providing instructions on the prescribed rehabilitation program;
- discharge from the hospital.
Observation period Visit 1 (Week 2)
- Removal of postoperative sutures
- Assessment of the implementation of the prescribed rehabilitation program;
- Providing further instructions on the prescribed rehabilitation program;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of body weight, BMI;
- Physical examination;
Visit 2 (Week 6)
- Assessment of the implementation of the prescribed rehabilitation program;
- Providing further instructions on the rehabilitation program;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Physical examination;
- Assessment according to the following scales: the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC)
- Assessment on the Modified Lysholm scale;
- MRI of the operated knee joint (ACLOAS);
- Preparation of an interim report to assess the safety of the material (for the first patient included in the study).
Visit 3 (Week 24-48)
- Assessment of the implementation of the prescribed rehabilitation program;
- Providing instructions on the prescribed rehabilitation program;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of body weight, BMI;
- Physical examination;
- Assessment according to the following scales: the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC)
- Assessment on the Modified Lysholm scale;
- MRI of the operated knee joint (ACLOAS).
For the collagen spacer of the first toe
Screening:
- Procedure for obtaining informed consent;
- Collection of demographic data, medical history;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of height, body weight, body mass index (BMI) (growth is estimated once per study - at screening);
- Physical examination;
- Evaluation of foot radiographs in two projections, functional MSCT (Multislice spiral computed tomography) of the foot
- Registration of the previous/concomitant therapy;
- Registration of pain therapy;
- Assessment of compliance with the inclusion/non-inclusion criteria;
For patients who meet the preliminary inclusion criteria and do not meet any of the criteria for non-inclusion in the screening, the date and time of the operation will be assigned.
The researcher gives the patient:
- Patient information sheet and informed consent form;
- Patient's card;
Hospitalization:
Day 1
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of body weight, BMI;
- Physical examination;
- Patients will be evaluated according to the scales: VAS (visual analog pain scale), AOFAS (American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score), SF-36 (36-Item Short Form Survey)
- Assessment of compliance with the inclusion/non-inclusion criteria;
- Assessment of exclusion criteria
Day 2 Surgical treatment: resection arthroplasty of the first metatarsophalangeal joint with implantation of a collagen spacer. After the operation, adverse events will be re-evaluated, symptomatic, analgesic therapy will be performed, and vital signs will be dynamically evaluated.
- Dressing of the postoperative wound
- Performing a control radiography of the operated feet in two projections
- Learning to walk in orthopedic shoes
Day 3-7 (Discharge)
- Assessment of adverse events, symptomatic, analgesic therapy;
- assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Walking in orthopedic shoes under the supervision of the attending physician;
- Dressing of the postoperative wound
- discharge from the hospital.
The observation period.
- Visit 1 (Week 2)
- Clinical examination
- Filling in evaluation scales by the patient
- Dressing of the postoperative wound, removal of stitches
- Performing a control radiography of the operated feet in two projections
- Evaluation of results (data from evaluation scales (VAS, AOFAS, SF-36), evaluation of functional and radiological results)
- Visit 2 (Week 4)
- Clinical examination
- Filling in evaluation scales by the patient
- Performing a control radiography of the operated feet in two projections
- Evaluation of the results (data from evaluation scales (VAS, AOFAS, SF-36), assessment of pain syndrome and amplitude of back flexion in the metatarsophalangeal joint and radiological result)
- Visit 3 (Week 8)
- Clinical examination
- Filling in evaluation scales by the patient
- Performing a control radiography of the operated feet in two projections
- Evaluation of the results (data from evaluation scales (VAS, AOFAS, SF-36), assessment of pain syndrome and amplitude of back flexion in the metatarsophalangeal joint and radiological result)
- Being tested
- Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane, Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group), Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity
- Keywords
- anterior cruciate ligament, hallux rigidus, ACL reconstruction, collagen membrane, collagen matrix
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cruciate ligament reconstruction, using graft, augmented with collagen membraneProcedure or surgery
Wrapping graft (tendon of the long fibular muscle) with collagen membrane before implantation
Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group)Procedure or surgery
Implantation of the native graft (tendon of the long fibular muscle) without any augmentation method
Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavityProcedure or surgery
Arthroplasty with consequent collagen membrane implantation
| Study group | Role | What they receive |
|---|---|---|
| The 1st group | Other | ACL reconstruction + collagen membrane Receives: Procedure: Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane |
| The 2nd group | Other | ACL reconstruction (control) Receives: Procedure: Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group) |
| The 3rd group | Other | Hallux Rigidus + collagen membrane Receives: Procedure: Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2, 4 and 8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexey V Lychagin, MD, PhD, Study chair, IM Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331741
- Sponsor's protocol ID
- 0403
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Collagen in Treatment of the Consequences of Injuries and Diseases of the Musculoskeletal System
- ClinicalTrials.gov ID
- NCT06331741
- Acronym / sponsor ID
- 0403
- Keywords
- anterior cruciate ligament, hallux rigidus, ACL reconstruction, collagen membrane, collagen matrix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Application of Collagen in Treatment of the Consequences of Injuries and Diseases of the Musculoskeletal System
Indications:
- Damage to the anterior cruciate ligament (ACL) of the knee joint
- Rigid first toe
Research centers:
University Clinical Hospital No. 1 of the First Sechenov Moscow State Medical University (Sechenov University)
The product under study:
The collagen membrane
Specifications:
-The product is a membrane made of type 1 collagen obtained from the ligaments of cattle. Chemically cross-linked with glutaraldehyde. The size of the membrane is 15x4x0.3 cm in dry form (can be adjusted depending on the patient's need).
Product shape: tape (medical device) Composition: type 1 collagen Packaging: in a sterilization bag Transportation: in a dry place, protected from light, at a temperature of 10 to 30 °C.
Shelf life: 2 years Storage: in a dry place, protected from light, at a temperature of 10 to 30 °C. Purpose: for implantation Storage conditions of the product: in a dry place, protected from light, at a temperature from 10 to 30 °C. Soak in saline solution for 10 minutes before use.
Sterilization: Steripak electron beam sterilization Manufacturer: Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Research objectives:
Tasks for the reconstruction of the ACL using a collagen membrane:
- Change in the score of the Form for registering the results of the knee joint examination of the International Knee Documentation Committee (IKDC);
- Change in the score of the Knee injury and Osteoarthritis Outcome Score (KOOS) relative to the baseline level;
- Change in the score of the Modified Lysholm scale relative to the initial level;
- Assessment of the condition of the transplant based on the results of control MRI data, measured on Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS)
Tasks for the application of collagen spacer of the first metatarsophalangeal joint:
- Formation of clinical groups of patients with 3-4 stages of Hallux rigidus.
- The development of personalized collagen, the formation of a membrane of the required size
- Formation of a unified protocol of the operational manual
- Development of a program of postoperative orthopedic regimen and rehabilitation
Assessment of the formation of syndesmosis by using instrumental research methods
Safety assessment parameters:
The frequency of adverse events and serious adverse events according to subjective complaints, physical examination, vital signs, ECG (Electrocardiography) and laboratory tests against the background of treatment using the technique of collagen membrane transplantation
The study population:
For the reconstruction of the anterior cruciate ligament using a collagen membrane:
men and women from 18 to 60 years old, with partial or complete damage to the anterior cruciate ligament, who will undergo autograft surgery, will be included in the work
For the collagen spacer of the first toe:
men and women from 18 to 60 years old, with 3-4 stages of Hallux rigidus, who will undergo resection arthroplasty with the introduction of a biocompatible collagen spacer into the joint cavity, will be included in the work
Number of patients:
10 patients with ACL damage 5 patients with a rigid first toe
Duration of the study:
For each patient - 12 months.
Research methodology:
Design for the reconstruction of the ACL using a collagen membrane:
The design involves the study of the medical device in experimental treatment groups in comparison with the control group.
The study group will initially include 5 patients. As a reference group, the results of treatment of 5 patients with ACL reconstruction by autograft.
Design for the collagen spacer of the first toe:
The study group will initially include 5 patients.
Description of the work stages:
For ACL reconstruction using a collagen membrane:
Screening:
- Procedure for obtaining informed consent;
- Collection of demographic data, medical history; registration of previous surgical interventions on the knee joint;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of height, body weight, body mass index (BMI) (growth is estimated once per study - at screening);
- Physical examination;
- Evaluation of MRI of the knee joint (ACLOAS);
- Registration of the previous/concomitant therapy;
- Registration of pain therapy;
- Assessment of compliance with the inclusion/non-inclusion criteria;
For patients who meet the preliminary inclusion criteria and do not meet any of the criteria for non-inclusion in the screening, the date and time of arthroscopy will be assigned.
The researcher gives the patient:
- Patient information sheet and informed consent form;
- Patient's card;
- Rehabilitation program.
Hospitalization:
Day 1
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of body weight, BMI;
- Physical examination;
- Patients will be assessed according to the following scales: the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC), assessment on the Modified Lysholm Scale
- Assessment of compliance with the inclusion/non-inclusion criteria;
- Assessment of exclusion criteria;
Day 2 Surgical treatment: ligament reconstruction. After surgery, adverse events, concomitant therapy, pain therapy, and vital signs will be re-evaluated.
Day 3-7 (Discharge)
- Assessment of adverse events, exclusion criteria, concomitant therapy, pain therapy;
- assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Providing instructions on the prescribed rehabilitation program;
- discharge from the hospital.
Observation period Visit 1 (Week 2)
- Removal of postoperative sutures
- Assessment of the implementation of the prescribed rehabilitation program;
- Providing further instructions on the prescribed rehabilitation program;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of body weight, BMI;
- Physical examination;
Visit 2 (Week 6)
- Assessment of the implementation of the prescribed rehabilitation program;
- Providing further instructions on the rehabilitation program;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Physical examination;
- Assessment according to the following scales: the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC)
- Assessment on the Modified Lysholm scale;
- MRI of the operated knee joint (ACLOAS);
- Preparation of an interim report to assess the safety of the material (for the first patient included in the study).
Visit 3 (Week 24-48)
- Assessment of the implementation of the prescribed rehabilitation program;
- Providing instructions on the prescribed rehabilitation program;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of body weight, BMI;
- Physical examination;
- Assessment according to the following scales: the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC)
- Assessment on the Modified Lysholm scale;
- MRI of the operated knee joint (ACLOAS).
For the collagen spacer of the first toe
Screening:
- Procedure for obtaining informed consent;
- Collection of demographic data, medical history;
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of height, body weight, body mass index (BMI) (growth is estimated once per study - at screening);
- Physical examination;
- Evaluation of foot radiographs in two projections, functional MSCT (Multislice spiral computed tomography) of the foot
- Registration of the previous/concomitant therapy;
- Registration of pain therapy;
- Assessment of compliance with the inclusion/non-inclusion criteria;
For patients who meet the preliminary inclusion criteria and do not meet any of the criteria for non-inclusion in the screening, the date and time of the operation will be assigned.
The researcher gives the patient:
- Patient information sheet and informed consent form;
- Patient's card;
Hospitalization:
Day 1
- Assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Measurement of body weight, BMI;
- Physical examination;
- Patients will be evaluated according to the scales: VAS (visual analog pain scale), AOFAS (American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score), SF-36 (36-Item Short Form Survey)
- Assessment of compliance with the inclusion/non-inclusion criteria;
- Assessment of exclusion criteria
Day 2 Surgical treatment: resection arthroplasty of the first metatarsophalangeal joint with implantation of a collagen spacer. After the operation, adverse events will be re-evaluated, symptomatic, analgesic therapy will be performed, and vital signs will be dynamically evaluated.
- Dressing of the postoperative wound
- Performing a control radiography of the operated feet in two projections
- Learning to walk in orthopedic shoes
Day 3-7 (Discharge)
- Assessment of adverse events, symptomatic, analgesic therapy;
- assessment of vital signs (blood pressure, heart rate, respiratory rate, t°);
- Walking in orthopedic shoes under the supervision of the attending physician;
- Dressing of the postoperative wound
- discharge from the hospital.
The observation period.
- Visit 1 (Week 2)
- Clinical examination
- Filling in evaluation scales by the patient
- Dressing of the postoperative wound, removal of stitches
- Performing a control radiography of the operated feet in two projections
- Evaluation of results (data from evaluation scales (VAS, AOFAS, SF-36), evaluation of functional and radiological results)
- Visit 2 (Week 4)
- Clinical examination
- Filling in evaluation scales by the patient
- Performing a control radiography of the operated feet in two projections
- Evaluation of the results (data from evaluation scales (VAS, AOFAS, SF-36), assessment of pain syndrome and amplitude of back flexion in the metatarsophalangeal joint and radiological result)
- Visit 3 (Week 8)
- Clinical examination
- Filling in evaluation scales by the patient
- Performing a control radiography of the operated feet in two projections
- Evaluation of the results (data from evaluation scales (VAS, AOFAS, SF-36), assessment of pain syndrome and amplitude of back flexion in the metatarsophalangeal joint and radiological result)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| The 1st group | Other | Procedure: Anterior cruciate ligament reconstruction, using graft, augmented with collagen membraneACL reconstruction + collagen membrane |
| The 2nd group | Other | Procedure: Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group)ACL reconstruction (control) |
| The 3rd group | Other | Procedure: Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavityHallux Rigidus + collagen membrane |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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.
- The type of degenerative disease of the first metatarsophalangeal joint is Hallux rigidus of stage 3-4.
Key exclusion criteria (6 listed)
- 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.
- Inclusion in the study in violation of the inclusion/non-inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior cruciate ligament reconstruction, using graft, augmented with collagen membraneWrapping graft (tendon of the long fibular muscle) with collagen membrane before implantation | Procedure or surgery | The 1st group |
| 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 or surgery | The 2nd group |
| Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavityArthroplasty with consequent collagen membrane implantation | Procedure or surgery | The 3rd group |
Primary outcome
The International Knee Documentation Committee score
Time frame: 1,5 and 6 months postoperatively
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
The Knee injury and Osteoarthritis Outcome Score
Time frame: 1,5 and 6 months postoperatively
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
Modified Lysholm scale
Time frame: 1,5 and 12 months postoperatively
Change in the score of the Modified Lysholm scale for ACL groups values: min - 0%; max - 100% The higher score means better outcome
Anterior Cruciate Ligament OsteoArthritis Score
Time frame: 6 months postoperatively
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
American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score
Time frame: 2, 4 and 8 weeks postoperatively
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
36-Item Short Form Survey
Time frame: 2, 4 and 8 weeks postoperatively
36-Item Short Form Survey (SF-36) for Hallux Rigidus group values: min - (0%); max - (100%) The higher score means better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey V Lychagin, MD, PhD study chair
IM Sechenov University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane and Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity in people with Anterior Cruciate Ligament Injuries and Hallux Rigidus, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina M Lipina, MD, PhD (+79253122096, marina.lipina@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The International Knee Documentation Committee score (time frame: 1,5 and 6 months postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.