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

NCT03307668 | Unknown DMC

• 1 other identifier: 3.0
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cartilage Defects

Outcome Measures

Primary Outcomes (1)

• Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups

  12 months

Secondary Outcomes (7)

• 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

Study Arms (2)

CaReS-1S

EXPERIMENTAL

Device: CaReSR-1S

Microfracture

ACTIVE COMPARATOR

Device: Microfracture

Interventions

CaReSR-1S DEVICE

CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.

CaReS-1S

Microfracture DEVICE

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.

Microfracture

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged from 18 to 55 years old;
• 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;
• Outerbridge degree of cartilage in the other articular facet ≤Ⅱ;
• Normal lower limb mechanical force line (varus or valgum \< 5°);
• Skeletal mature;
• Kg/M2 ≤ BMI ≤ 30Kg/M2;
• Agree to sign the informed consent form;
• Can cooperate in a post-operative rehabilitation program.

You may not qualify if:

• Superficial cartilage defects;
• Concomitant with subchondral bone defect;
• Varus or valgum \> 5°;
• Serious meniscus injury;
• Fractures around the knee;
• Cannot join in the post-operative rehabilitation program;
• The contralateral lower-limb cannot stand weight-bearing;
• A history of knee surgery within 6 months;
• Secondary arthritis affecting cartilage;
• Serious arthrocleisis;
• Undergoing clinical trial;
• Serious illness of the heart, lung, and other vital organs;
• 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;
• Have a contagious disease;
• Allergic to the agents;

Sponsors & Collaborators

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

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Subchondral

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Central Study Contacts

Dong-xing Xie, PhD

CONTACT

86073189753006; 491703175@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: October 12, 2017
• Study Start: January 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 12, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)