Beijing Jishuitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100035, China
NCT Number: NCT07149896
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
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Phase 3
Beijing, Beijing Municipality, 100035, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Time frame: Preoperatively, 1st week, 1st month, 3rd month, and 6th month postoperatively
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
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
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
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
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 postoperative complications in each group, such as infection, hematoma, severe pain, joint adhesions, nerve damage, etc.
Contact information is provided by the study sponsor or research team.
Beijing Jishuitan Hospital
Other
A Prospective Randomized Controlled Study Of Collagen Scaffold For The Repair Of Elbow Cartilage Injury
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