Trials / Unknown
UnknownNCT03321812
Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Peking University Third Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | decalcification bone scaffold | Decalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage. |
| PROCEDURE | microfracture | Microfracture is the surgical option for conventional treatment of cartilage defects. |
Timeline
- Start date
- 2018-09-11
- Primary completion
- 2023-12-30
- Completion
- 2023-12-30
- First posted
- 2017-10-26
- Last updated
- 2020-07-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03321812. Inclusion in this directory is not an endorsement.