Tissue Engineered Cartilage to Repairing Articular Cartilage Defects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Xinxiang Medical College
About this trial
The joint cartilage constructed by combining bone marrow mesenchymal stem cells with three-dimensional materials has achieved the goal of repairing joint cartilage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patients' age ranges from 18 to 65 years old, and gender is not restricted;
The imaging results show that the epiphyseal growth is mature;
The defects or localized injuries of joint cartilage caused by trauma or other reasons;
The injured area is the distal weight-bearing surface of the femoral condyle of the knee joint, with no more than 4 lesions, and there is no injury to the cruciate ligaments;
Disqualifiers
The patient is extremely overweight, with a body mass index greater than 35;
The lower limb alignment is valgus by more than 10° and varus by more than 5°;
Multiple ligament injuries;
There are numerous bad habits such as heavy smoking, drug abuse, and excessive alcohol consumption;
Trial design
Design model
Single group
Treatments tested in this trial
Tissue engineered cartilage
DeviceCartilage constructed by autologous bone marrow mesenchymal stem cells
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Tissue-engineered cartilage to repair articular cartilage defectsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
KSS score
subjective knee clinical and functional score (0-100)score.100 is better in function
Time frame
before the operation, at 3, 6, 12 and 24 months after the operation.Secondary outcomes
1
Koos scores
subjective knee functional score (0-100)score.100 is better in function
Time frame
before the operation, at 3, 6, 12 and 24 months after the operation.2
Lysholm score
subjective knee functional score (0-100)score.100 is better in function
Time frame
before the operation, at 3, 6, 12 and 24 months after the operation.3
WOMAC score
The higher the index, the more severe the osteoarthritis. It is less than 80 for mild cases, 80 to 120 for moderate cases, and more than 120 for severe cases.
Time frame
before the operation, at 3, 6, 12 and 24 months after the operation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov