- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03303690
AS: Ankle Spacer for Talar Osteochondral Defects (AS)
July 14, 2020 updated by: Jari Dahmen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Noord Holland
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Amsterdam, Noord Holland, Netherlands, 1105AZ
- Academic Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ankle Spacer (AS)
This arm will surgically receive the to be implanted ankle spacer in their ankle.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NRS during walking/weightbearing
Time Frame: 2 years postoperatively
|
The primary study parameter is the measurement of the NRS
|
2 years postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
|
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
|
pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
|
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.
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Other outcome measures will include the AOFAS.
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pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
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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.
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Other outcome measures will include FAOS
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pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
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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.
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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.
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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.
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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.
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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
|
pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
|
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.
|
pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
|
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.
|
pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
|
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.
|
pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: G.M.M.J. Kerkhoffs, MD PhD, Academic Medical Center (AMC Amsterdam)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 5, 2017
Primary Completion (ACTUAL)
March 11, 2020
Study Completion (ACTUAL)
March 11, 2020
Study Registration Dates
First Submitted
September 17, 2017
First Submitted That Met QC Criteria
October 5, 2017
First Posted (ACTUAL)
October 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 15, 2020
Last Update Submitted That Met QC Criteria
July 14, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GK2017AS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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