Cartilage InjuryNCT03321812
Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
A study testing decalcification bone scaffold and microfracture in people with Cartilage Injury, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cartilage Injury
- What is being tested?
- decalcification bone scaffold and microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2018to 30 Dec 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 years old, male or female
- Cartilage defect 2-8 cm²
- Subjects have the surgical indication of microfracture and no contradiction
- Subjects participate the clinical trial voluntarily, and sign informed consent
- Subjects could comply with follow-up
Who cannot join
- Participated in other drug or medical device clinical trials in the last 6 months.
- Can not accept allogeneic decalcified bone due to religion, ethnic and other issues.
- Defect area 2 cm² or 8 cm² or lack of normal cartilage tissue around defect zone.
- Complex multi-ligament injury
- Suffered from systemic immune disease or systemic, locally infected
- Joint fibrosis, joint rigidity, mobility was significantly limited
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- Moderate and severe osteoarthritis
- With contraindications to MRI
- Hemophilia
- General condition can not tolerate surgery
- Pregnant or planned pregnant women and lactating women
- With abnormal spirit and selfless ability
- Other circumstances judged by doctors that can not participate in the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine
Beijing, Beijing Municipality, 100000
Xiaoqing Hu, Phd, +8613401096777, aoyingfang@163.com
About this study
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.
Read the 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
- Cartilage Injury
- Being tested
- decalcification bone scaffold, microfracture
- Keywords
- decalcification bone scaffold, microfracture, randomized controlled trial, cartilage lesions of the knee
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decalcification bone scaffoldProcedure or surgery
Decalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage.
microfractureProcedure or surgery
Microfracture is the surgical option for conventional treatment of cartilage defects.
| Study group | Role | What they receive |
|---|---|---|
| decalcification bone scaffold | Experimental | Decalcification bone scaffold is a novel tissue engineered acellular matrix scaffold with the closest biomechanics and structure to normal cartilage. Receives: Procedure: decalcification bone scaffold; Procedure: microfracture |
| Microfracture | Active comparator | Microfracture is a conventional treatment for cartilage lesions of the knee. Receives: Procedure: microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appraise of magnetic reasonance imaging
Evaluate the articular cartilage postoperatively by MRI.
Measured: 5 years
Secondary outcomes (4)
Lysholm score
The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.
Measured: 5 years
International Knee Documentation Committee (IKDC) 2000
International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
Measured: 5 years
Tegner activity level score
The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.
Measured: 5 years
Visual analogue scale
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. From 0 to 10, no pain 0, worst pain imaginable 10. The higher values represent a worse outcome.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start11 Sep 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage InjuryStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ao Yingfang, Peking University Third Hospital
- Investigators
- Yingfang Ao, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321812
- Sponsor's protocol ID
- PKU-AO-01
- Status last verified
- Jun 2020
- First submitted
- 23 Oct 2017
- Last updated
- 2 Jul 2020
- Results posted
- No
- 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 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
- ClinicalTrials.gov ID
- NCT03321812
- Acronym / sponsor ID
- PKU-AO-01
- Conditions
- Cartilage Injury
- Keywords
- decalcification bone scaffold, microfracture, randomized controlled trial, cartilage lesions of the knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 26 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| decalcification bone scaffold | Experimental | Procedure: decalcification bone scaffold, Procedure: microfractureDecalcification bone scaffold is a novel tissue engineered acellular matrix scaffold with the closest biomechanics and structure to normal cartilage. |
| Microfracture | Active comparator | Procedure: microfractureMicrofracture is a conventional treatment for cartilage lesions of the knee. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-50 years old, male or female
- Cartilage defect 2-8 cm²
- Subjects have the surgical indication of microfracture and no contradiction
- Subjects participate the clinical trial voluntarily, and sign informed consent
- Subjects could comply with follow-up
Key exclusion criteria (13 listed)
- Participated in other drug or medical device clinical trials in the last 6 months.
- Can not accept allogeneic decalcified bone due to religion, ethnic and other issues.
- Defect area 2 cm² or 8 cm² or lack of normal cartilage tissue around defect zone.
- Complex multi-ligament injury
- Suffered from systemic immune disease or systemic, locally infected
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 |
|---|---|---|
| decalcification bone scaffoldDecalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage. | Procedure or surgery | decalcification bone scaffold |
| microfractureMicrofracture is the surgical option for conventional treatment of cartilage defects. | Procedure or surgery | Microfracture, decalcification bone scaffold |
Primary outcome
Appraise of magnetic reasonance imaging
Time frame: 5 years
Evaluate the articular cartilage postoperatively by MRI.
4 secondary outcomes
Lysholm score
Time frame: 5 years
International Knee Documentation Committee (IKDC) 2000
Time frame: 5 years
Tegner activity level score
Time frame: 5 years
Visual analogue scale
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Yingfang Ao, MD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decalcification bone scaffold and microfracture in people with Cartilage Injury, run by Peking University Third Hospital 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 5 inclusion and 13 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 2 Jul 2020. 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 Xiaoqing Hu, phd (+8613401096777, aoyingfang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appraise of magnetic reasonance imaging (time frame: 5 years). 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 2 Jul 2020.