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AS: Ankle Spacer for Talar Osteochondral Defects (AS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03303690
Recruitment Status : Terminated (Arthrex stopped manufacturing the device)
First Posted : October 6, 2017
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Jari Dahmen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date  ICMJE September 17, 2017
First Posted Date  ICMJE October 6, 2017
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE December 5, 2017
Actual Primary Completion Date March 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
NRS during walking/weightbearing [ Time Frame: 2 years postoperatively ]
The primary study parameter is the measurement of the NRS
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • NRS at rest and during stairclimbing [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing
  • NRS during stairclimbing [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing
  • AOFAS (American Orthopedic Foot and Ankle Score) [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    Other outcome measures will include the AOFAS.
  • FAOS (Foot and Ankle Outcome Score) [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    Other outcome measures will include FAOS
  • SF-36 (Short-Form 36) Physical Component Scale [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    Other outcome measures will include SF-36 Physical Component Scale
  • SF-36 (Short-Form 36) Mental Component Scale [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    Other outcome measures will include SF-36 Mental Component Scale
  • ROM (range of motion) [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    Other outcome measures will include Range of Motion (ROM) in degrees of dorsi- and plantarflexion and will be measured using a goniometer
  • demographic data: sex [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    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.
  • demographic data: age [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    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.
  • Radiographic evaluation [ Time Frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop. ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AS: Ankle Spacer for Talar Osteochondral Defects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Ankle sprains can result in talar osteochondral defects (OCDs) which have a significant impact on the quality of life of patients. When these OCDs are of large nature (anterior-posterior or medial-lateral diameter >1.5cm in diameter), cystic, have failed prior surgical treatment, or when there are multiple present on the talar articular surface, surgical care by means of fixation or bone marrow stimulation is contra-indicated. An ankle arthrodesis or fusion can be considered, but this results in functional limitation due to a decreased range of motion (ROM). In order to serve for a bone sparing prosthesis procedure, preserve range of motion, optimize physical functioning and to resurface the talus, the Ankle Spacer has been developed. It is a one-piece implant system that replaces the articulating upper talus surface of the tibio-talar joint, and offers several implant sizes in order to fit to the different talus sizes. It is anatomically designed to the native upper talus surface to provide an optimal fit to the distal articular surface. It has a rough titanium plasma spray (TPS) coated under surface with two posts and spikes for implant fixation. The rough surface enables secondary fixation by means of bone ingrowth and the spikes at the posterior part of the prosthesis allowing for optimal adherence of the implant and for minimal iatrogenic damage upon fixation. By these means, the anatomical situation and the natural congruency of the ankle joint are mirrored to a optimal extent. Despite the fact that no clinical trials have been published on this specific implant, it is hypothesized that the 5-year postoperative clinical outcomes concerning pain and prosthesis survival will be considered good.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteochondral Defect of Talus
Intervention  ICMJE Procedure: Ankle Spacer (AS)
All included patients will be treated by means of surgical implantation of the Ankle Spacer prosthesis in an open manner replacing the talar side of the tibiotalar joint.
Study Arms  ICMJE Experimental: Ankle Spacer (AS)
This arm will surgically receive the to be implanted ankle spacer in their ankle.
Intervention: Procedure: Ankle Spacer (AS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 14, 2020)
2
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2017)
20
Actual Study Completion Date  ICMJE March 11, 2020
Actual Primary Completion Date March 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03303690
Other Study ID Numbers  ICMJE GK2017AS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jari Dahmen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: G.M.M.J. Kerkhoffs, MD PhD Academic Medical Center (AMC Amsterdam)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP