Cartilage DefectsNCT03307668
Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee
A study testing CaReSR-1S and Microfracture in people with Cartilage Defects, run by Arthro-Anda Tianjin Biologic Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Defects
- What is being tested?
- CaReSR-1S and Microfracture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
- 18Kg/M2 ≤ BMI ≤ 30Kg/M2;
- Agree to sign the informed consent form;
- Can cooperate in a post-operative rehabilitation program.
Who cannot join
- 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;
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- 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;
- Lactating or pregnant women;
- Serious neuropathy or mental disease;
- Be addicted with drug or alcohol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Guang-hua Lei
About this study
Official title: 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.
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.
- Conditions
- Cartilage Defects
- Being tested
- CaReSR-1S, Microfracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaReSR-1SDevice
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.
MicrofractureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CaReS-1S | Experimental | Not described Receives: Device: CaReSR-1S |
| Microfracture | Active comparator | Not described Receives: Device: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups
Measured: 12 months
Secondary outcomes (7)
Difference of MOCART score change from baseline between groups
Measured: 12 months
Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups
Measured: 12 months
Difference of Lysholm score change from baseline between groups
Measured: 12 months
"Good""Moderate""Poor" rates according to Lysholm score
Measured: 12 months
Effective rate according to Lysholm score
Measured: 12 months
Total efficiency according to Lysholm score
Measured: 12 months
Incidence of treatment-related adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 Jan 2014
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthro-Anda Tianjin Biologic Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307668
- Sponsor's protocol ID
- 3.0
- Status last verified
- Oct 2017
- First submitted
- 24 Aug 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee: a Randomised, Multicentre, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT03307668
- Acronym / sponsor ID
- 3.0
- Conditions
- Cartilage Defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Arthro-Anda Tianjin Biologic Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CaReS-1S | Experimental | Device: CaReSR-1S |
| Microfracture | Active comparator | Device: Microfracture |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (18 listed)
- Superficial cartilage defects;
- Concomitant with subchondral bone defect;
- Varus or valgum > 5°;
- Serious meniscus injury;
- Fractures around the knee;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaReSR-1SCaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I. | Device | CaReS-1S |
| MicrofractureMicrofracture 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. | Device | Microfracture |
Primary outcome
Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups
Time frame: 12 months
7 secondary outcomes
Difference of MOCART score change from baseline between groups
Time frame: 12 months
Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups
Time frame: 12 months
Difference of Lysholm score change from baseline between groups
Time frame: 12 months
"Good""Moderate""Poor" rates according to Lysholm score
Time frame: 12 months
Effective rate according to Lysholm score
Time frame: 12 months
Total efficiency according to Lysholm score
Time frame: 12 months
Incidence of treatment-related adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Cartilage Defects
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaReSR-1S and Microfracture in people with Cartilage Defects, run by Arthro-Anda Tianjin Biologic Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-xing Xie, PhD (86073189753006, 491703175@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.