Osteochondral Fracture of Talus Clinical Trial
— OLTOfficial title:
Randomized, Multicentric, Prospective, Double-blind Study: Effectiveness of Adding Allogenic Stem Cells to a Platelet-poor Plasma Scaffold After Arthroscopic Debridement and Microfractures in Patients With Osteochondral Lesions of the Talus
Randomized, multicentric, prospective, double-blind study: effectiveness of adding allogenic
stem cells to a platelet-poor plasma scaffold after arthroscopic debridement and
microfractures in patients with osteochondral lesions of the talus Osteochondral lesions of
the talus (LOC), affects the ankle cartilage, which it seems to have less repair capacity
than that of other joints such as the knee of the hip. The LOC can be an important source of
pain and affects comparatively younger, working age and athletically active patients.
Although there are several therapeutic strategies, debridement and microfractures performed
arthroscopically are the most frequent procedures. After this surgery, it is expected that
fibrocartilage will form that covers the osteochondral lesion. Though good results have been
reported, this fibrocartilage presents histological characteristics of lower quality to those
of the native articular cartilage.
Based on previous studies in different joints, it is hypothesized that the augmentation
treatment of osteochondral lesions of the talus with mesenchymal allogeneic stromal cells
derived from the umbilical cord produces better clinical and imaging results than standard
treatment with debridement and microfractures only.
Therefore, the present study seeks to compare the effectiveness of traditional debridement
and microfracture treatment versus adding a platelet-poor plasma (PPP) scaffold embedded in
allogeneic mesenchymal stromal cells derived from the umbilical cord in patients with
osteochondral lesions of the talus.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with a symptomatic osteochondral lesion of the Talus. - Magnetic resonance of the ankle showing osteochondral injury of a single talus, with perilesional oedema Exclusion Criteria: - Recurrent osteochondral lesions of the talus - Multiple osteochondral lesions - Severe ankle instability, requiring open repair - History of a previous foot or ankle surgery of the ipsilateral foot - Rheumatoid arthritis - Inability to return to the surgery site to practice long-term follow-up evaluations or lack of readiness to complete the indicated evaluation forms. - Patients with a qualitative or quantitative commitment that prevents consent or assent their participation in the study. |
Country | Name | City | State |
---|---|---|---|
Chile | Universidad de Chile Clinical Hospital | Santiago | Independencia |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change on tissue reparation quality | Magnetic resonance observation of cartilage repair tissue (MOCART). The MOCART classification is one of the most frequently used MR score for postoperative cartilage repair tissue evaluation. The MOCART score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score. | Baseline and 1 year follow up | |
Primary | Change over time of general health status | The MOS SF-36, It is a generic scale to evaluate health/disease status. It comprises 36 items divided into two components: Physical Health (PH) and Mental Health (MH). PH includes four subscales: Physical Function (PF), Role Physical (RP), Bodily Pain (BP), and General Health (GH). MH includes four subscales: Vitality (V), Social functioning (SF), Role Emotional (RE), and General Health (GH). Each component (PH and MH) and each of the eight subscale scores are transformed into a 0-to-100 scale. Higher scores represent better health status |
Baseline, 1 year and 2 years follow up | |
Primary | Change over time of functional limitations of foot and ankle. | The Foot and Ankle Outcome Score (FAOS) evaluates functional limitations related to foot and ankle issues. Consist in 42 items that cover 5 dimensions: Symptoms (S: 7 items), Pain (P: 9 items), Activities of Daily Living (ADL: 17 items), Sport and Recreation Activities (SRA: 5 items), and foot and ankle related Quality of Life (QoL: 4 items). Raw scores of each sub-scales results of the sum of each item score. These raw scores are standardised into a 0 to 100 scale; higher scores mean higher dysfunction due to foot/ankle condition. |
Baseline, 1 year and 2 years follow up | |
Primary | Change over time of functionality of musculoskeletal ankle and foot pathology | The Foot and Ankle Ability Measure (FAAM) scale aims to evaluate overtime changes in the functionality of the same patient in musculoskeletal ankle and foot pathology. It is a survey that consists of 21 items about activities of daily living, and 8 items about sports skills. Raw scores of each sub-scales are standardised into a 0 to 100 scale; higher scores mean higher dysfunction due to foot/ankle condition. |
Baseline, 1 year and 2 years follow up | |
Primary | Change on declared pain | Visual Analog Scale for Pain (VAS-Pain): a pain rating scale based on self-reported measures of symptoms. A 10cm line numbered from 0 to 10 represents a continuum between "no pain" (zero) and "worst pain" (ten). It can also be interpreted as a 0-to-100 points score. |
Baseline, 1 year and 2 years follow up | |
Secondary | Surgical time | Duration (in minutes) of the surgery | During surgery | |
Secondary | Complication rate | Including the number of participants with: post-surgery infections temporal or permanent damage of nerve as a result of pressure or hematoma with venose thrombosis, pulmonary embolism or heart stroke |
Two years follow up from baseline (surgery) | |
Secondary | Cost-effective comparative analysis | Comparison of the overall costs and results of both groups | Two years follow up from baseline (surgery) |