Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee

Study Overview
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Brief Summary
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The trial evaluates the clinical efficacy and safety of decalcification bone scaffold for cartilage lesions of the knee. Half of participants will receive decalcification bone scaffold combined with microfracture, while the other will only receive microfracture as a control group.

Detailed Description
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Decalcification bone scaffold is a tissue engineering scaffold with the closest biomechanics and structure of normal cartilage. The objective of the study is to evaluate the clinical efficacy of arthroscopic decalcification bone scaffold combined with microfracture in the repairment of articular cartilage defects by randomized controlled trial. Sixty patients with clinically diagnosed knee cartilage injury according to 1: 1 were divided into experimental group and control group. The experimental group will be treated with decalcification bone scaffold combined with microfracture .The control group will be treated with microfracture . The patients will be treated by the same surgeon in this study group. MRI evaluation, Lysholm score, IKDC score, Tegner score, VAS score are selected as the measures of outcome, while the blood routine, blood biochemistry, urine, CRP, ECG and other laboratory tests will be recorded inclduing the incidence of adverse events.

Official Title
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Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee

Conditions
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Cartilage Injury

Intervention / Treatment
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* Procedure: decalcification bone scaffold
* Procedure: microfracture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-50 years old, male or female Cartilage defect 2-8 cm² Subjects have the surgical indication of microfracture and no contradiction Subjects participate the clinical trial voluntarily, and sign informed consent Subjects could comply with follow-up Exclusion Criteria: Participated in other drug or medical device clinical trials in the last 6 months. Can not accept allogeneic decalcified bone due to religion, ethnic and other issues. Defect area 2 cm² or 8 cm² or lack of normal cartilage tissue around defect zone. Complex multi-ligament injury Suffered from systemic immune disease or systemic, locally infected Joint fibrosis, joint rigidity, mobility was significantly limited Moderate and severe osteoarthritis With contraindications to MRI Hemophilia General condition can not tolerate surgery Pregnant or planned pregnant women and lactating women With abnormal spirit and selfless ability Other circumstances judged by doctors that can not participate in the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: decalcification bone scaffold<br>Decalcification bone scaffold is a novel tissue engineered acellular matrix scaffold with the closest biomechanics and structure to normal cartilage. | Procedure: decalcification bone scaffold<br>* Decalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage.<br>Procedure: microfracture<br>* Microfracture is the surgical option for conventional treatment of cartilage defects.<br>|
| Active Comparator: Microfracture<br>Microfracture is a conventional treatment for cartilage lesions of the knee. | Procedure: microfracture<br>* Microfracture is the surgical option for conventional treatment of cartilage defects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appraise of magnetic reasonance imaging | Evaluate the articular cartilage postoperatively by MRI. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm score | The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome. | 5 years | 
| International Knee Documentation Committee (IKDC) 2000 | International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome. | 5 years | 
| Tegner activity level score | The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome. | 5 years | 
| Visual analogue scale | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. From 0 to 10, no pain 0, worst pain imaginable 10. The higher values represent a worse outcome. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decalcification bone scaffold, microfracture, randomized controlled trial, cartilage lesions of the knee