Osteochondral Defect of Talus Clinical Trial
— ASOfficial title:
A Prospective Trial on the Clinical Efficacy of the Ankle Spacer for the Surgical Treatment of Large, Multiple, Cystic and Secondary or Tertiary Osteochondral Defects of the Talus
| Verified date | July 2020 |
| Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
By means of the Ankle Spacer patients will be implanted, the clinical and radiological results of which will be prospectively recorded and analyzed at different points in time.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | March 11, 2020 |
| Est. primary completion date | March 11, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - age ranging from 18 to 80 years - talar osteochondral defect (multiple degenerative talar cysts present, and/or prior failed surgical treatment and/or multiple defects and/or large (>15mm)) - willing to receive surgical implantation of the Ankle Spacer - has been informed of the nature of the study and provided written consent - The subject and treating physician agree that the subject will return for all required post-procedure follow-up visits - failed previous conservative treatment - complaints for at least 6 months Exclusion Criteria: - -severe ankle malalignement.(> 5° varus/valgus). - fracture < 6 months - tendinitis - diabetes mellitus / rheumathoid arthritis - advanced osteoporosis - grade two or higher (Kellgren-Lawrence-Score) ankle joint degeneration on the tibia side. - any ankle deformation that does not allow proper rasping of the cartilage and/or proper seating of the desired sized implant, as described in the surgical technique. - blood supply limitations and previous infections, which may retard healing. - foreign-body sensitivity. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. - active infection or blood supply limitations. - conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period, including severe neuro-arthropathy. - pathological conditions, such as insufficient quantity or quality of bone (e.g., cystic changes or severe osteopenia), which may compromise implant fixation. - currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints. - Inability to be brought back to the surgery site for long term follow-up evaluations or the subject is unwilling to fill out the appropriate evaluation forms - adiposity grade I (BMI > 30 kg/m2) |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Academic Medical Center | Amsterdam | Noord Holland |
| Lead Sponsor | Collaborator |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | NRS during walking/weightbearing | The primary study parameter is the measurement of the NRS | 2 years postoperatively | |
| Secondary | NRS at rest and during stairclimbing | Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. | |
| Secondary | NRS during stairclimbing | Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. | |
| Secondary | AOFAS (American Orthopedic Foot and Ankle Score) | Other outcome measures will include the AOFAS. | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. | |
| Secondary | FAOS (Foot and Ankle Outcome Score) | Other outcome measures will include FAOS | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. | |
| Secondary | SF-36 (Short-Form 36) Physical Component Scale | Other outcome measures will include SF-36 Physical Component Scale | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. | |
| Secondary | SF-36 (Short-Form 36) Mental Component Scale | Other outcome measures will include SF-36 Mental Component Scale | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. | |
| Secondary | ROM (range of motion) | Other outcome measures will include Range of Motion (ROM) in degrees of dorsi- and plantarflexion and will be measured using a goniometer | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. | |
| Secondary | demographic data: sex | Other study parameters that will be recorded are demographic data and also radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded. | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. | |
| Secondary | demographic data: age | Other study parameters that will be recorded are demographic data and also radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded. | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. | |
| Secondary | Radiographic evaluation | Radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded. | pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. |