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Showing 1-17 of 17 trials
NCT04537013
Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.
NCT07057037
The goal of this Phase 3 clinical trial is to evaluate whether MR arthrography enhanced with NEMO-103 injection (NEMO-103 Inj.) provides superior diagnostic imaging quality compared to unenhanced MRI in patients with known or suspected shoulder joint disorders, such as rotator cuff tendon tears, labral tears, and articular cartilage injuries. ⦁ The primary objective is to determine whether NEMO-103 Inj.-enhanced MR arthrography offers improved imaging quality in terms of joint distension, contrast resolution, and image sharpness compared to standard unenhanced MRI. Participation Details: * Each participant will undergo two MRI scans: one unenhanced and one enhanced with NEMO-103 Inj. * NEMO-103 Inj. will be administered once, during the second study visit. * Participants will attend a total of three site visits.
NCT06344481
The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment.
NCT04184687
The aim of the study is the evaluation of both clinical and radiological results in patients undergone to cruciate ligament reconstruction with concomitant cartilaginous lesion treated with or without nanofractures.
NCT02636881
82 patients aged 18-49 years with an isolated focal cartilage defect in the knee will be randomized to either receive autologous cartilage implantation or arthroscopic debridement. Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The Groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D (European Quality of Life 5 dimensions) as well as clinical examination and radiological findings at 2 years (MRI).
NCT06400862
The objective of the study is to establish the safety profile of the autologous engineered osteochondral tissues (eOCT) in treating traumatic chondral lesions in patients.
NCT04889443
SHARC is an observational study of cartilage patients who are treated with surgery that involves obtaining a harvest biopsy. SHARC will study the natural healing process of the harvest biopsy site based on histological and biochemical analyses of repair tissue biopsies, synovial fluid biomarkers, medical imaging (MRI) and gait analysis.
NCT06220539
Rationale: OCLs (osteochondral lesions) of the talus can be congenital or can occur after trauma or in patients with juvenile idiopathic arthritis (JIA). The main complaint of an OCL is pain during weightbearing activities. Therefore, these lesions have significant impact on the health status of patients. Objective: The aim of this study is to optimize the treatment for skeletally immature patients with an osteochondral lesion. The hypothesis is that a period of immobilization and supervised rehabilitation will lead to better clinical and radiological outcomes compared with standard care which is a ''skill-full'' neglect. Study design: Observational comparative study Study population: Skeletally immature children with an osteochondral lesion of the talus diagnosed on CT. Intervention: Patients in the intervention group will undergo an 8-week period of casting and walking on crutches. Afterwards, they will receive a protocolled period of rehabilitation under supervision of a physical therapist. The control group will have the standard care as treatment. Main study parameters/endpoints: the main study outcome is the difference between the two groups on the OxAFQ-C. Secondary study outcomes are radiologic changes in terms of morphology and lesion size, NRS during weight bearing and quality of life measured with a Peds-QL, EQ-5D-y and AAS. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden that patients will have is mainly the time that they have to spent on fulfilling the questionnaires.
NCT05433012
Study population The investigator set the sample size to 200 patients. Primary outcome * Diagnostic accuracy of ultrahigh field MRI (T7) compared to high field MRI (T3 or less) for detection of meniscal injuries associated with acute ACL injury Secondary outcome * Influence of 1) Location of injury and 2) meniscal tear pattern (modified WORMS18,19) on the sensitivity of high field MRI compared to ultrahigh field MRI for detection of meniscal tears
NCT02430558
Patient with IKDC score \< 65, pretreated with mosaicplasty or ACI ( with matrix or not) within \> 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty.
NCT01473199
Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device.
NCT05124613
The Covid-19 pandemic has led to the postponement and cancellation of elective orthopaedic surgeries worldwide. These delays to elective procedures combined with ongoing demand have led to increasingly longer waiting list times. This cross-sectional pilot study aims to investigate the change in patients' perceptions of knee pain and function since being waitlisted for surgery. A bespoke survey will be administered to eligible patients over the phone from Trafford General Hospital, Manchester. The survey will also investigate the coping mechanisms and the preventative measures patients are taking to manage symptoms during the pandemic, and question what kinds of communication and support patient would like to be offered whilst waiting for treatment. This study will improve clinicians' and researchers' understanding of how patients are coping with symptoms during this pandemic, and provide information on how to better support patients who are waiting for knee surgery. This information could be used to enhance orthopaedic care during, and in the aftermath, of this pandemic. The information gathered in this study may also be used to inform a larger multi-centre study.
NCT05120700
A phase I/II clinical trial (first in human) to assess the effectiveness and safety of the treatment of cartilage injury with a tissue engineering construct composed of stromal vascular fraction collected from the synovial membrane and infrapatellar fat of the injured knee, submitted to enzymatic processing in a single surgical time, associated with a collagen scaffold. The primary outcomes will be assessed by 3T magnetic resonance imaging, quality of life and knee function questionnaires, in addition to perioperative and post-operative complications. Secondary outcomes will be evaluated by measuring the health resources used to ensure compatibility, reproducibility and generalizability of the technique. The authors believe that adverse events will be similar to current surgical procedures and that there will be an improvement in knee function scores and quality of life of patients undergoing the procedure.
NCT03479775
The aims of the project are to 1) evaluate different aspects of muscle function and its role as a potential risk and/or protective factor for traumatic knee injury in youth female athletes; 2) develop and evaluate a battery of muscle function tests, easily used and requiring minimal equipment, to be applied as an on-the-field screening tool to detect muscle function deficiencies and monitoring youth female athletes at high risk of traumatic knee injury. A prospective cohort design will be used, including approximately 100 female athletes (age 15-19) from Swedish senior sports high schools who are involved in high risk sports (soccer, handball, floorball and basket). A test battery for muscle function has been developed consisting of 11 tests that previously have been used for the assessment of muscle function. The tests will be instructed and supervised by educated test leaders. Measurements will take place at the athletes' school and carried out during the first semester (autumn 2017 and 2018). Data on injury surveillance and exposure (hours of match and training participation) will be collected prospectively over two years using a web-designed registration form. All athletes will on a weekly basis report their hours of training, minutes of match play and all time-loss injuries occurring during sport activity. Details on injury mechanism and diagnosis will be collected by each school's medical staff. The present study will contribute new knowledge on the role of muscle function and develop and evaluate a battery of muscle function tests to be used as an on-the-field screening tool for monitoring youth female athletes at high risk of traumatic knee injury.
NCT02309957
Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.
NCT03024801
To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage repair and evaluating functional recovery of the knee joint in knee cartilage injury patients.
NCT01689337
This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to evaluate the efficacy and safety of Sprifermin (AS902330) (recombinant human fibroblast growth factor-18 \[rhFGF-18\]) as an adjunct treatment to subjects following microfracture (MFx) surgery for cartilage injury of the knee. Primary Objectives * To evaluate the effect of Sprifermin (AS902330) intra-articular knee injections as adjunct to microfracture (MFx) surgery on the composition of the refilled cartilage in the target knee, as measured by gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) time constant 1 (T1) relaxation time at 6 months after MFx surgery * To evaluate the safety profile of Sprifermin (AS902330) when administered intra-articular into the knee as adjunct to MFx surgery in subjects with cartilage injury of the knee Secondary Objectives * To further support the efficacy and safety of Sprifermin (AS902330) as an adjunct to MFx for cartilage injury repair through symptomatic outcomes and quantitative MRI measurement