Cartilage DefectPhase 3NCT07149896
A Study of Collagen Scaffold for the Repair of Elbow Cartilage Injury
A Phase 3 study testing Collagen Scaffold (Colla-Plug) and microfracture in people with Cartilage Defect and Elbow Injury, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair in elbow joint injuries, compared to standard surgery alone. The study will enroll 90 patients (aged 18-55) with elbow cartilage damage who haven't responded to conservative treatments. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Defect, Elbow Injury
- What is being tested?
- Collagen Scaffold (Colla-Plug) and microfracture
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Subjects are between the ages of 18 and 55 (including 18 and 55 years old);
- Articular cartilage defect reaches Outerbridge grade III/IV;
- The area of cartilage defect in a single site is 0.5cm²-2cm²;
- BMI 18≤BMI≤30;
- Clinically diagnosed cartilage defect requiring arthroscopic microfracture;
- Have not participated in other clinical trials within 3 months;
- Conservative treatment such as rest/topical/oral non-steroidal anti-inflammatory drugs for more than 3 months has not been effective
- Subjects fully understand the benefits and risks of this trial, are willing to participate and sign the informed consent form, and are able to cooperate with clinical follow-up.
Who cannot join
- Obvious narrowing of the elbow joint space or bone ankylosis formed between joints;
- Severe subchondral bone injury that cannot be undergoing microfracture surgery;
- Those with severe elbow deformity or systemic osteoarticular diseases;
- Secondary elbow arthritis with psoriasis, syphilitic neuropathy, brown yellow disease, metabolic bone disease;
- Elbow joint cartilage damage caused by joint fractures, infections, tumors, and immune diseases;
- Elbow joint tumors, rheumatoid, tuberculosis, suppuration and complications affecting the joint structure;
Show all 15Show fewer
- Those who have undergone cartilage defect transplantation from bone marrow mesenchymal stem cell transplantation or other cartilage regeneration surgery within 12 months before surgery;
- Allergies, such as porcine protein allergy, past history or family history of autoimmune diseases;
- Those who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs;
- Combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases, mental illness;
- Those who cannot receive long-term and complex rehabilitation training after surgery;
- Women who are planning to have children, breastfeeding and pregnant women within 12 months;
- Those who have contraindications to MRI examination;
- Those who have special beliefs and cannot accept it (the product source is pig source);
- Those who are not suitable for inclusion by other researchers, such as those who cannot be judged for efficacy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Jishuitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100035
Yi Lu, 86-010-57801282, luyi_sports@126.com
About this study
Official title: A Prospective Randomized Controlled Study Of Collagen Scaffold For The Repair Of Elbow Cartilage Injury
The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair in elbow joint injuries, compared to standard surgery alone. The study will enroll 90 patients (aged 18-55) with elbow cartilage damage who haven't responded to conservative treatments.
The main questions it aims to answer are:
Read more
- Does the collagen scaffold help regenerate better-quality cartilage (measured by MRI scans at 3 and 6 months)?
- Do patients experience better pain relief and elbow function after this combined treatment?
Researchers will compare two groups:
- Experimental group : Receives microfracture surgery + collagen scaffold implant
- Active Comparator group : Receives microfracture surgery alone
Participants will:
- Undergo arthroscopic surgery (either procedure)
- Complete follow-up visits at 1 week, 1 month, 3 months, and 6 months
- Have MRI scans and functional assessments
- Report pain levels and daily activity limitations through questionnaires
- Conditions
- Cartilage Defect, Elbow Injury
- Being tested
- Collagen Scaffold (Colla-Plug), microfracture
- Keywords
- elbow cartilage defect, collagen scaffold
- Medical subject headings
- Elbow Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Scaffold (Colla-Plug)Device
The collagen cartilage scaffold(COLTRIX® CartiRegen) used in this study consist of an injection needle, a syringe, and a collagen gel prefilled in a syringe. The collagen gel contains phosphate buffer and type Ⅰ collagen which the telopeptides are removed.. After the product is implanted in the body, it forms a degradable three-dimensional scaffold to provide an environment for cells to adhere, proliferate, migrate, differentiate and secrete, thereby promoting cartilage repair. At present, it has been commercially applied to clinical repair of knee cartilage defect.
microfractureProcedure or surgery
Microfracture to repair cartilage defect is a minimally invasive procedure that is usually done arthroscopically. The doctor first cleans the damaged cartilage area, and then uses a special microfracture cone to drill vertically in the subchondral bone plate, forming multiple tiny holes, allowing mesenchymal stem cells and growth factors in the bone marrow to overflow, forming a blood clot rich in repair components, and finally stimulating fibrocartilage regeneration to fill the defect area.
| Study group | Role | What they receive |
|---|---|---|
| Microfracture + Collagen scaffold | Experimental | After performing arthroscopic microfracture (with a cone tip spacing of 2-3mm and a depth reaching the subchondral bone), the defect site is dried using a suction tube and cotton swabs. A double-chamber syringe is used to inject the collagen scaffold, which will be then shaped and cured. Afterward, physiological saline is reinfused, and the stability of the graft is assessed under arthroscopy during the full range of motion of the elbow joint. Receives: Device: Collagen Scaffold (Colla-Plug); Procedure: microfracture |
| Microfracture | Active comparator | Conventional arthroscopic microfracture operation is carried out, and the operation process of the experimental group is simulated by simulated drying and lavage during the operation. Receives: Procedure: microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score
The MOCART scoring system is a standardized assessment tool based on magnetic resonance imaging (MRI) specifically designed to quantify the morphological effects after articular cartilage repair. The scoring system uses a 100-point system (minimum score of 0, maximum score of 100), with higher scores representing better repair results. A total score of ≥75 indicates that the repaired tissue is close to normal hyaline cartilage in terms of structure, integration, and signal strength, while a score below 50 indicates poor repair effect or risk of complications. The assessment covered seven core indicators: volume filling of cartilage defects (0-20), integration with adjacent cartilage margins (0-15), repaired tissue surface structure (0-10), repaired tissue structure (0-10), repaired tissue signal intensity (0-15), subchondral bone changes (0-20), and bone quality changes (0-10).
Measured: Preoperatively, 3rd and 6th months postoperatively
Secondary outcomes (6)
Visual Analogue Scale(VAS)
The VAS scoring system is a standardized subjective symptom assessment tool designed based on the principle of visual simulation, with a core form of a 10 cm long straight line, with a minimum score of 0 (representing no symptoms) and a maximum value of 10 (representing the most severe symptoms), with higher scores indicating more severe symptoms.
Measured: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Mayo Elbow Performance Score(MEPS)
The Mayo Elbow Performance Score (MEPS) is a standardized tool for quantitatively assessing elbow function, with a score ranging from 0-100 , with higher scores indicating better elbow joint function (e.g.≥, 90 points are "excellent", 75-89 points are "good", and 60-74 points are "acceptable", <60 points are "poor"). The scoring system is evaluated comprehensively through four core dimensions: 1. Pain (0-45 points): graded according to pain frequency and severity, no pain is a full score, and loss of mobility is 0 points; 2. Motor function (0-20 points): based on flexion and extension mobility (20 points are scored for 100° of motion arc≥ only 5 points are scored for 50° of <); 3. Stability (0-10 points): evaluate the degree of varus laxity (no full score for relaxation, 0 points for obvious instability); 4. Daily living ability (0-25 points): Test five actions (combing hair, eating, personal hygiene, wearing shirts, shoes), 5 points for each item.
Measured: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Oxford Elbow Score(OES)
The Oxford Elbow Score (OES) is a self-rated standardized instrument for assessing elbow disease or postoperative functional recovery on a scale of 0-100, with higher scores indicating better elbow function (e.g., better pain control, mobility, and quality of life). The scoring system consists of three aspects: 1. Elbow pain (4 questions, assessing pain frequency, intensity and impact on life); 2. Elbow function (4 questions, test mobility, grasp and daily activities); 3. Psychosocial impact (4 questions, focusing on social, emotional and appearance satisfaction).
Measured: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Disabilities of the Arm, Shoulder and Hand(DASH)
The DASH scoring system is a standardized self-assessment tool for quantifying the assessment of upper extremity dysfunction on a scale of 0-100, with higher scores indicating more severe upper limb dysfunction (e.g., pain, limited mobility, and more significant impact on life). The scale consists of 30 core questions covering two main areas:1. Functional disability (21 questions): Evaluate daily living ability (such as opening doors, lifting objects, writing, dressing); 2. Symptoms and social impact (9 questions): quantify pain, numbness, sleep disturbance, and social/work limitations.
Measured: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Range of motion
Normal mobility is the basis for maintaining daily movements, and restriction or excessive can lead to functional impairment. Elbow range of motion is divided into four directions, as follows: flexion, extension, pronation, and supination
Measured: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Rate of Complications
Rate of postoperative complications in each group, such as infection, hematoma, severe pain, joint adhesions, nerve damage, etc.
Measured: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cartilage DefectStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Lu, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149896
- Sponsor's protocol ID
- K20250509-02
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will share the medical history and physical examination, imaging data (X-ray, CT, MRI, etc.) , functional scores, laboratory test results and complications of the two groups of patients with elbow cartilage defect.
Publications
Shetty AA, Kim SJ, Bilagi P, Stelzeneder D. Autologous collagen-induced chondrogenesis: single-stage arthroscopic cartilage repair technique. Orthopedics. 2013 May;36(5):e648-52. doi: 10.3928/01477447-20130426-30.
PubMed 23672920Shetty AA, Kim SJ, Shetty V, Jang JD, Huh SW, Lee DH. Autologous collagen induced chondrogenesis (ACIC: Shetty-Kim technique) - A matrix based acellular single stage arthroscopic cartilage repair technique. J Clin Orthop Trauma. 2016 Jul-Sep;7(3):164-9. doi: 10.1016/j.jcot.2016.05.003. Epub 2016 Jun 14.
PubMed 27489411Kim SJ, Shetty AA, Kurian NM, Ahmed S, Shetty N, Stelzeneder D, Shin YW, Cho YJ, Lee SH. Articular cartilage repair using autologous collagen-induced chondrogenesis (ACIC): a pragmatic and cost-effective enhancement of a traditional technique. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2598-2603. doi: 10.1007/s00167-020-05884-y. Epub 2020 Feb 17.
PubMed 32064573Jeong IH, Shetty AA, Kim SJ, Jang JD, Kim YJ, Chung YG, Choi NY, Liu CH. Autologous collagen-induced chondrogenesis using fibrin and atelocollagen mixture. Cells Tissues Organs. 2013;198(4):278-88. doi: 10.1159/000356488. Epub 2013 Dec 20.
PubMed 24356241
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study Of Collagen Scaffold For The Repair Of Elbow Cartilage Injury
- ClinicalTrials.gov ID
- NCT07149896
- Acronym / sponsor ID
- K20250509-02
- Conditions
- Cartilage Defect, Elbow Injury
- Keywords
- elbow cartilage defect, collagen scaffold
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Sep 2025 (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 goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair in elbow joint injuries, compared to standard surgery alone. The study will enroll 90 patients (aged 18-55) with elbow cartilage damage who haven't responded to conservative treatments.
The main questions it aims to answer are:
- Does the collagen scaffold help regenerate better-quality cartilage (measured by MRI scans at 3 and 6 months)?
- Do patients experience better pain relief and elbow function after this combined treatment?
Researchers will compare two groups:
- Experimental group : Receives microfracture surgery + collagen scaffold implant
- Active Comparator group : Receives microfracture surgery alone
Participants will:
- Undergo arthroscopic surgery (either procedure)
- Complete follow-up visits at 1 week, 1 month, 3 months, and 6 months
- Have MRI scans and functional assessments
- Report pain levels and daily activity limitations through questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microfracture + Collagen scaffold | Experimental | Device: Collagen Scaffold (Colla-Plug), Procedure: microfractureAfter performing arthroscopic microfracture (with a cone tip spacing of 2-3mm and a depth reaching the subchondral bone), the defect site is dried using a suction tube and cotton swabs. A double-chamber syringe is used to inject the collagen scaffold, which will be then shaped and cured. Afterward, physiological saline is reinfused, and the stability of the graft is assessed under arthroscopy during the full range of motion of the elbow joint. |
| Microfracture | Active comparator | Procedure: microfractureConventional arthroscopic microfracture operation is carried out, and the operation process of the experimental group is simulated by simulated drying and lavage during the operation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects are between the ages of 18 and 55 (including 18 and 55 years old);
- Articular cartilage defect reaches Outerbridge grade III/IV;
- The area of cartilage defect in a single site is 0.5cm²-2cm²;
- BMI 18≤BMI≤30;
- Clinically diagnosed cartilage defect requiring arthroscopic microfracture;
Key exclusion criteria (15 listed)
- Obvious narrowing of the elbow joint space or bone ankylosis formed between joints;
- Severe subchondral bone injury that cannot be undergoing microfracture surgery;
- Those with severe elbow deformity or systemic osteoarticular diseases;
- Secondary elbow arthritis with psoriasis, syphilitic neuropathy, brown yellow disease, metabolic bone disease;
- Elbow joint cartilage damage caused by joint fractures, infections, tumors, and immune diseases;
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 |
|---|---|---|
| Collagen Scaffold (Colla-Plug)The collagen cartilage scaffold(COLTRIX® CartiRegen) used in this study consist of an injection needle, a syringe, and a collagen gel prefilled in a syringe. The collagen gel contains phosphate buffer and type Ⅰ collagen which the telopeptides are removed.. After the product is implanted in the body, it forms a degradable three-dimensional scaffold to provide an environment for cells to adhere, proliferate, migrate, differentiate and secrete, thereby promoting cartilage repair. At present, it has been commercially applied to clinical repair of knee cartilage defect. | Device | Microfracture + Collagen scaffold |
| microfractureMicrofracture to repair cartilage defect is a minimally invasive procedure that is usually done arthroscopically. The doctor first cleans the damaged cartilage area, and then uses a special microfracture cone to drill vertically in the subchondral bone plate, forming multiple tiny holes, allowing mesenchymal stem cells and growth factors in the bone marrow to overflow, forming a blood clot rich in repair components, and finally stimulating fibrocartilage regeneration to fill the defect area. | Procedure or surgery | Microfracture, Microfracture + Collagen scaffold |
Primary outcome
MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score
Time frame: Preoperatively, 3rd and 6th months postoperatively
The MOCART scoring system is a standardized assessment tool based on magnetic resonance imaging (MRI) specifically designed to quantify the morphological effects after articular cartilage repair. The scoring system uses a 100-point system (minimum score of 0, maximum score of 100), with higher scores representing better repair results. A total score of ≥75 indicates that the repaired tissue is close to normal hyaline cartilage in terms of structure, integration, and signal strength, while a score below 50 indicates poor repair effect or risk of complications. The assessment covered seven core indicators: volume filling of cartilage defects (0-20), integration with adjacent cartilage margins (0-15), repaired tissue surface structure (0-10), repaired tissue structure (0-10), repaired tissue signal intensity (0-15), subchondral bone changes (0-20), and bone quality changes (0-10).
6 secondary outcomes
Visual Analogue Scale(VAS)
Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Mayo Elbow Performance Score(MEPS)
Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Oxford Elbow Score(OES)
Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Disabilities of the Arm, Shoulder and Hand(DASH)
Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Range of motion
Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Rate of Complications
Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Results publication: PubMed 23672920Shetty AA, Kim SJ, Bilagi P, Stelzeneder D. Autologous collagen-induced chondrogenesis: single-stage arthroscopic cartilage repair technique. Orthopedics. 2013 May;36(5):e648-52. doi: 10.3928/01477447-20130426-30.
- Results publication: PubMed 27489411Shetty AA, Kim SJ, Shetty V, Jang JD, Huh SW, Lee DH. Autologous collagen induced chondrogenesis (ACIC: Shetty-Kim technique) - A matrix based acellular single stage arthroscopic cartilage repair technique. J Clin Orthop Trauma. 2016 Jul-Sep;7(3):164-9. doi: 10.1016/j.jcot.2016.05.003. Epub 2016 Jun 14.
- Results publication: PubMed 32064573Kim SJ, Shetty AA, Kurian NM, Ahmed S, Shetty N, Stelzeneder D, Shin YW, Cho YJ, Lee SH. Articular cartilage repair using autologous collagen-induced chondrogenesis (ACIC): a pragmatic and cost-effective enhancement of a traditional technique. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2598-2603. doi: 10.1007/s00167-020-05884-y. Epub 2020 Feb 17.
- Results publication: PubMed 24356241Jeong IH, Shetty AA, Kim SJ, Jang JD, Kim YJ, Chung YG, Choi NY, Liu CH. Autologous collagen-induced chondrogenesis using fibrin and atelocollagen mixture. Cells Tissues Organs. 2013;198(4):278-88. doi: 10.1159/000356488. Epub 2013 Dec 20.
- Individual participant dataSharing planned: Yes. This study will share the medical history and physical examination, imaging data (X-ray, CT, MRI, etc.) , functional scores, laboratory test results and complications of the two groups of patients with elbow cartilage defect.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collagen Scaffold (Colla-Plug) and microfracture in people with Cartilage Defect and Elbow Injury, run by Beijing Jishuitan 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 8 inclusion and 15 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: opening soon, as of the sponsor's last update on 2 Sep 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Lu (86-010-57801282, luyi_sports@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score (time frame: Preoperatively, 3rd and 6th months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149896, which also lists 4 linked publications.
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 Sep 2025.