A Phase 3 interventional study of Collagen Scaffold (Colla-Plug) and microfracture in Cartilage Defect and Elbow Injury, sponsored by Beijing Jishuitan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Beijing Jishuitan Hospital · Phase 3, Interventional, and Treatment
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:
Researchers will compare two groups:
Participants will:
21 studies on the registry are indexed under Elbow Injuries; 6 are open to participants now.
This study's planned enrollment of 90 is above the median of 52 across 13 interventional studies indexed under Elbow Injuries.
Browse Elbow Injuries studies →Beijing Jishuitan Hospital is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Collagen Scaffold (Colla-Plug) · Procedure: microfracture
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.
Procedure: microfracture
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.
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.
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).
Time frame: Preoperatively, 3rd and 6th months postoperatively
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Start is estimated for Aug 2025; primary completion for Dec 2026, 16 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing Jishuitan Hospital