A RCT of Collagen Scaffold for the Repair of Talus Cartilage Injury
A Prospective Randomized Controlled Study Of Collagen Scaffold For The Repair Of Talus Cartilage Injury
The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair of talus injury, compared to standard surgery alone. The study will enroll 40 patients (aged 18-55) with talus 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 3/6 months and 1/2 years)?
- Do patients experience better pain relief and ankle 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, 6 months, 1 year and 2 years
- Have MRI scans and functional assessments
- Report pain levels and daily activity limitations through questionnaires
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina
- Beijing Jishuitan Hospital, Capital Medical University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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 1cm²-3cm²;
- BMI 18≤BMI≤30;
- Clinically diagnosed cartilage defect requiring arthroscopic microfracture;
- Have not participated in other clinical trials within 3 months;
- Conservative treatment 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
Exclusion Criteria:
- Subjects with significant narrowing of the ankle joint space or bony ankylosis (bone bridge formation).
- Subjects with severe subchondral bone damage unsuitable for microfracture surgery.
- Subjects with severe ankle deformity or systemic bone/joint diseases.
- Subjects with allergic predisposition (e.g., porcine protein allergy) or personal/family history of autoimmune diseases.
- Subjects who received autologous bone marrow mesenchymal stem cell transplantation or other cartilage regeneration surgery for cartilage defects in the affected ankle within 12 months prior to surgery.
- Subjects whose ankle cartilage injury was caused by articular fractures, infections, tumors, or immune-mediated diseases.
- Subjects with ankle tumors, rheumatoid arthritis, tuberculosis, suppurative arthritis, or complications affecting joint structure.
- Subjects with secondary ankle arthritis accompanied by psoriasis, syphilitic neuropathy, ochronosis, or metabolic bone diseases.
- Subjects with frequent use of sedatives, hypnotics, tranquilizers, or other addictive drugs.
- Subjects with severe primary cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic system diseases, or psychiatric disorders.
- Subjects unable to comply with long-term intensive postoperative rehabilitation.
- Female subjects planning pregnancy within 12 months, or currently pregnant or lactating.
- Subjects with specific religious beliefs prohibiting porcine-derived products.
- Other subjects deemed ineligible by investigators (e.g., inability to evaluate treatment efficacy).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Mikrobrudd
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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. |
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Eksperimentell: Microfracture + Collagen scaffold
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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MOCART score
Tidsramme: Preoperatively, 3rd and 6th months and 1st and 2nd postoperatively
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The MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scoring system includes multiple dimensions such as the morphology of the repaired tissue, the thickness of the repaired cartilage, the signal intensity of the repaired tissue, the integration of the repaired cartilage with normal cartilage, the bone quality under the repaired cartilage, the accumulation or inflammation of the joint cavity, and the coverage of cartilage defects. Morphology and its integration with the surrounding normal cartilage. |
Preoperatively, 3rd and 6th months and 1st and 2nd postoperatively
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Range of motion
Tidsramme: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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The range of motion (ROM), measured in degrees (°) using the neutral-zero method, includes: sagittal plane dorsiflexion (0°-20°) and plantarflexion (0°-50°) at the talocrural joint, and frontal plane/horizontal plane inversion (0°-35°) and eversion (0°-15° to 20°) at the subtalar joint. Anatomically, the neutral reference position is 90° between the foot and leg, with the goniometer axis placed inferior to the lateral malleolus or midpoint of the bimalleolar line, the stationary arm aligned with the fibular/leg axis, and the moving arm aligned with the 5th metatarsal or calcaneus axis. Active and passive ROM should be documented separately, with unilateral findings compared to the contralateral side to assess restriction. |
Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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Visual Analogue Scale(VAS)
Tidsramme: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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A Visual Analogue Scale (VAS) is a straight-line measurement tool where respondents mark their perceived intensity of a symptom-such as pain-along a continuous 0-100 mm continuum. |
Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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Kellgren-Lawrence Grade
Tidsramme: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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The Kellgren-Lawrence (KL) grade is a standardized radiological scoring system (grades 0-4) used to classify the severity of osteoarthritis based on features such as joint space narrowing, osteophytes, and subchondral sclerosis. |
Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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Tegner score
Tidsramme: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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The Tegner score is a clinician-reported scale (0-10) that rates a patient's activity level by linking knee function to the demands of specific sports and occupational activities. |
Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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American Orthopedic Foot and Ankle Society Score (AOFAS)
Tidsramme: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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The AOFAS score is a clinician-based 100-point ankle-foot rating system that evaluates pain, function, and alignment to assess outcomes in foot and ankle disorders. |
Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kim 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.
- Shetty 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- K20250509-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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 talus cartilage defect.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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