Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee

Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee: a Randomised, Multicentre, Open-label, Controlled Trial

The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.

Study Overview

• Status: Unknown
• Conditions: Cartilage Defects
• Intervention / Treatment: Device: CaReSR-1S; Device: Microfracture

Detailed Description

CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I. It is indicated for the defect filling of focal, full layer and clearly defined knee and ankle cartilage defects of longest diameter 1.1-2.2cm. The fixation of CaReSR-1S is made for all sizes with fibrin glue, whereas the 11 mm implants also allow a press-fit anchoring due to the elasticity of the implant.

The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as progenitor cells from the surrounding healthy tissue.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital, Central South University
      • Contact: Guang-hua Lei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged from 18 to 55 years old;
2. Diagnosed with isolated knee cartilage defects in condyles of femur by arthroscopy, and the longest diameter is 1.1-2.2cm. The degree of the cartilage defects is Outerbridge IV degree or III degree but approximate to IV degree;
3. Outerbridge degree of cartilage in the other articular facet ≤Ⅱ;
4. Normal lower limb mechanical force line (varus or valgum < 5°);
5. Skeletal mature;
6. 18Kg/M2 ≤ BMI ≤ 30Kg/M2;
7. Agree to sign the informed consent form;
8. Can cooperate in a post-operative rehabilitation program.

Exclusion Criteria:

1. Superficial cartilage defects;
2. Concomitant with subchondral bone defect;
3. Varus or valgum > 5°;
4. Serious meniscus injury;
5. Fractures around the knee;
6. Cannot join in the post-operative rehabilitation program;
7. The contralateral lower-limb cannot stand weight-bearing;
8. A history of knee surgery within 6 months;
9. Secondary arthritis affecting cartilage;
10. Serious arthrocleisis;
11. Undergoing clinical trial;
12. Serious illness of the heart, lung, and other vital organs;
13. Liver function test equal to two times or greater than the upper normal limits; serum creatinine equal to two times or greater than the upper normal limit;
14. Have a contagious disease;
15. Allergic to the agents;
16. Lactating or pregnant women;
17. Serious neuropathy or mental disease;
18. Be addicted with drug or alcohol.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microfracture	Device: Microfracture; Microfracture is an articular cartilage repair surgical technique that works by creating tiny fractures in the underlying bone. This causes new cartilage to develop from a so-called super-clot.
Experimental: CaReS-1S	Device: CaReSR-1S; CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference of MOCART score change from baseline between groups	12 months
Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups	12 months
Difference of Lysholm score change from baseline between groups	12 months
"Good""Moderate""Poor" rates according to Lysholm score	12 months
Effective rate according to Lysholm score	12 months
Total efficiency according to Lysholm score	12 months
Incidence of treatment-related adverse events	12 months

Collaborators and Investigators

• Sponsor: Arthro-Anda Tianjin Biologic Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 3.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No