Clinical trial NCT03321812: Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
Official title: Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cartilage Injury
Keywords: decalcification bone scaffold
microfracture
randomized controlled trial
cartilage lesions of the knee
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Appraise of magnetic reasonance imaging
timeFrame: 5 years
Secondary outcomes:
measure: Lysholm score
timeFrame: 5 years
measure: International Knee Documentation Committee (IKDC) 2000
timeFrame: 5 years
measure: Tegner activity level score
timeFrame: 5 years
measure: Visual analogue scale
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yingfang Ao, MD
role: PRINCIPAL_INVESTIGATOR
References: