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Status unknownNCT03307668Updated Oct 12, 2017

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

An interventional study of CaReSR-1S and Microfracture in Cartilage Defects, sponsored by Arthro-Anda Tianjin Biologic Technology Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-10-12.

Sponsored by Arthro-Anda Tianjin Biologic Technology Co., Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cartilage Defects
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    CaReS-1S

    Device: CaReSR-1S

  • Active comparator
    Microfracture

    Device: Microfracture

Interventions

  • DeviceCaReSR-1S

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

  • DeviceMicrofracture

    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.

05

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Difference of MOCART score change from baseline between groups

    Time frame: 12 months

  2. Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups

    Time frame: 12 months

  3. Difference of Lysholm score change from baseline between groups

    Time frame: 12 months

  4. "Good""Moderate""Poor" rates according to Lysholm score

    Time frame: 12 months

  5. Effective rate according to Lysholm score

    Time frame: 12 months

  6. Total efficiency according to Lysholm score

    Time frame: 12 months

  7. Incidence of treatment-related adverse events

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • Xiangya Hospital, Central South University
    Changsha, Hunan 410008, China
    • Guang-hua Lei · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03307668
Lead sponsor
Arthro-Anda Tianjin Biologic Technology Co., Ltd.
Responsible party
Sponsor
First posted
Oct 12, 2017
Start date
Jan 1, 2014
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Oct 12, 2017

Study contacts

Dong-xing Xie, PhD
Contact
491703175@qq.com
86073189753006

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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