Ankle OsteoarthritisTARGETNCT05729958
Total Ankle Replacement Using Guides, Expert Versus Trainee
An observational study of Ankle Osteoarthritis, run by Centre for Orthopaedic Research Alkmaar.
Trial summary
Patient Specific Instrumentation (PSI) is thought to quicken joint arthroplasty surgery by shortening the operation time and improving alignment. Studies about the learning curve of PSI for total ankle replacement (TAR) are lacking because it was only introduced in 2014. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ankle Osteoarthritis
- What is being tested?
- CT scan
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that received primary TAR pre-operatively planned using PROPHECY PSI in 2022. Both traumatic and non-traumatic osteoarthritis are included.
Who may be able to join
- Patient can understand the study's meaning and is willing to sign the study-specific Informed Patient Consent Form.
- Patient received the implantation of Infinity or Inbone prosthesis using PROPHECY PSI for primary TAR in 2022.
- There are at least 3 months of follow-up data for this patient.
- Patient can lay still during the length of duration of the CT-scan.
Who cannot join
- If per-operative the use of the PSI guides was abandoned.
- Patients that underwent revision surgery (defined as original tibia of talar component change or removal).
- Patients that endured other diseases that significantly impacted the post-operative period following TAR (e.g. amputation, severe extremity dysfunction due to a neurological or vascular impairment or trauma).
About this study
Patient Specific Instrumentation (PSI) is thought to quicken joint arthroplasty surgery by shortening the operation time and improving alignment. Studies about the learning curve of PSI for total ankle replacement (TAR) are lacking because it was only introduced in 2014.
The investigators believe that PSI could give a beginning ankle surgeon, or surgeons new to TAR, an advantage since PSI facilitates the complex TAR procedure. As such, the availability of TAR in Dutch patients with end-stage ankle osteoarthritis could be extended. To estimate this potential of PSI for TAR, the investigators aim (1) to compare the alignment accuracy of TAR performed using PSI between a beginning and an experienced orthopedic surgeon, and (2) to determine the learning curve of TAR performed using PSI for a beginning foot and ankle specialist by comparing the operative time, complications, and patient-reported outcomes with those of an experienced specialist.
Read the detailed description
Total ankle replacement (TAR) as treatment of end-stage osteoarthritis of the ankle is gaining popularity past few years, resulting in a growing number of TAR placed each year. This is an important progression because osteoarthritis of the ankle is suggested to be as disabling as chronic kidney injury or heart failure. Though TAR is proposed to be superior to ankle arthrodesis (AA) with regard to patient quality of life, it is not commonly available in the Netherlands. Merely 149 TARs were registered nationally in 2020.
Patient Specific Instrumentation (PSI) is thought to quicken the process by shortening the operation time and improving alignment. Though the literature is submerged in studies about the learning curves of PSI and TAR, research about the learning curve of PSI TAR is lacking because it was only introduced in 2014. Preliminary results showed that the use of PSI resulted in lower average pain scores and earlier recovery compared to TAR using standard instrumentation. Yet the absolute advantage of PSI was not established because of limited research. Furthermore, all previous studies were performed by skilled surgeons to eliminate the bias of inexperience.
The investigators believe that PSI could give a beginning ankle surgeon, or surgeon new to TAR, an advantage since PSI facilitates the complex TAR procedure. As such, the availability of TAR in Dutch patients with end-stage ankle osteoarthritis could be extended. To estimate this potential of PSI for TAR, the investigators aim (1) to compare the alignment accuracy of TAR performed using PSI between a beginning and an experienced orthopedic surgeon, and (2) to determine the learning curve of TAR performed using PSI for a beginning foot and ankle specialist by comparing the operative time, complications, and patient-reported outcomes with those of an experienced specialist. It is hypothesized that the alignment of PSI TAR performed by a beginning orthopedic surgeon does not significantly differ from one performed by an experienced surgeon. Furthermore, it is hypothesized that the operative time, complications, and patient-reported outcomes do not significantly differ between a beginning and an experienced orthopedic surgeon.
- Conditions
- Ankle Osteoarthritis
- Being tested
- CT scan
- Keywords
- Arthroplasty, Patient-specific Instrumentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
CT scan of the involved ankle
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative TAR component accuracy
Difference between the planned and obtained (anterior and sagittal) tibia angles.
Measured: 2-year follow-up assessment
Secondary outcomes (3)
Foot and Ankle Outcome Score (FAOS)
The FAOS was developed to assess the patients' opinion about a variety of foot and ankle-related problems. FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 2-year follow-up assessment
Foot Function Index (FFI)
The FFI (questionnaire) consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability, and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), which best describes their foot over the past week.
The pain subcategory consists of 9 items and measures foot pain in different situations, such as walking barefoot versus walking with shoes.
The disability subcategory consists of 9 items and measures difficulty performing various functional activities because of foot problems, such as difficulty climbing stairs.
The activity limitation subcategory consists of 5 items and measures limitations in activities because of foot problems, such as staying in bed all day. Recorded on a visual analog scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain.
Measured: 2-year follow-up assessment
American Orthopedic Foot and Ankle Score (AOFAS)
This clinical rating system combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability, and alignment of the ankle-hindfoot). The scale includes 9 items that can be divided into 3 subscales (pain, function, and alignment). Pain consists of 1 item with a maximal score of 40 points, indicating no pain. Function consists of 7 items with a maximal score of 50 points, indicating full function. Alignment consists of 1 item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments.
Measured: 2-year follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study startApr 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Orthopaedic Research Alkmaar
- Sponsor type
- University, hospital or other
- Collaborators
- Noordwest Ziekenhuisgroep
- Responsible party
- Principal investigator, Joyce L Benner, PhD, Centre for Orthopaedic Research Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729958
- Sponsor's protocol ID
- NL83260.018.22
- Acronym
- TARGET
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Ankle Replacement Using Guides, Expert Versus Trainee
- ClinicalTrials.gov ID
- NCT05729958
- Acronym / sponsor ID
- TARGET / NL83260.018.22
- Conditions
- Ankle Osteoarthritis
- Keywords
- Arthroplasty, Patient-specific Instrumentation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre for Orthopaedic Research AlkmaarUniversity, hospital or other
- Collaborators
- Noordwest Ziekenhuisgroep
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient Specific Instrumentation (PSI) is thought to quicken joint arthroplasty surgery by shortening the operation time and improving alignment. Studies about the learning curve of PSI for total ankle replacement (TAR) are lacking because it was only introduced in 2014.
The investigators believe that PSI could give a beginning ankle surgeon, or surgeons new to TAR, an advantage since PSI facilitates the complex TAR procedure. As such, the availability of TAR in Dutch patients with end-stage ankle osteoarthritis could be extended. To estimate this potential of PSI for TAR, the investigators aim (1) to compare the alignment accuracy of TAR performed using PSI between a beginning and an experienced orthopedic surgeon, and (2) to determine the learning curve of TAR performed using PSI for a beginning foot and ankle specialist by comparing the operative time, complications, and patient-reported outcomes with those of an experienced specialist.
Detailed description
Total ankle replacement (TAR) as treatment of end-stage osteoarthritis of the ankle is gaining popularity past few years, resulting in a growing number of TAR placed each year. This is an important progression because osteoarthritis of the ankle is suggested to be as disabling as chronic kidney injury or heart failure. Though TAR is proposed to be superior to ankle arthrodesis (AA) with regard to patient quality of life, it is not commonly available in the Netherlands. Merely 149 TARs were registered nationally in 2020.
Patient Specific Instrumentation (PSI) is thought to quicken the process by shortening the operation time and improving alignment. Though the literature is submerged in studies about the learning curves of PSI and TAR, research about the learning curve of PSI TAR is lacking because it was only introduced in 2014. Preliminary results showed that the use of PSI resulted in lower average pain scores and earlier recovery compared to TAR using standard instrumentation. Yet the absolute advantage of PSI was not established because of limited research. Furthermore, all previous studies were performed by skilled surgeons to eliminate the bias of inexperience.
The investigators believe that PSI could give a beginning ankle surgeon, or surgeon new to TAR, an advantage since PSI facilitates the complex TAR procedure. As such, the availability of TAR in Dutch patients with end-stage ankle osteoarthritis could be extended. To estimate this potential of PSI for TAR, the investigators aim (1) to compare the alignment accuracy of TAR performed using PSI between a beginning and an experienced orthopedic surgeon, and (2) to determine the learning curve of TAR performed using PSI for a beginning foot and ankle specialist by comparing the operative time, complications, and patient-reported outcomes with those of an experienced specialist. It is hypothesized that the alignment of PSI TAR performed by a beginning orthopedic surgeon does not significantly differ from one performed by an experienced surgeon. Furthermore, it is hypothesized that the operative time, complications, and patient-reported outcomes do not significantly differ between a beginning and an experienced orthopedic surgeon.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that received primary TAR pre-operatively planned using PROPHECY PSI in 2022. Both traumatic and non-traumatic osteoarthritis are included.
Key inclusion criteria (4 listed)
- Patient can understand the study's meaning and is willing to sign the study-specific Informed Patient Consent Form.
- Patient received the implantation of Infinity or Inbone prosthesis using PROPHECY PSI for primary TAR in 2022.
- There are at least 3 months of follow-up data for this patient.
- Patient can lay still during the length of duration of the CT-scan.
Key exclusion criteria (3 listed)
- If per-operative the use of the PSI guides was abandoned.
- Patients that underwent revision surgery (defined as original tibia of talar component change or removal).
- Patients that endured other diseases that significantly impacted the post-operative period following TAR (e.g. amputation, severe extremity dysfunction due to a neurological or vascular impairment or trauma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanCT scan of the involved ankle | Diagnostic test | – |
Primary outcome
Postoperative TAR component accuracy
Time frame: 2-year follow-up assessment
Difference between the planned and obtained (anterior and sagittal) tibia angles.
3 secondary outcomes
Foot and Ankle Outcome Score (FAOS)
Time frame: 2-year follow-up assessment
Foot Function Index (FFI)
Time frame: 2-year follow-up assessment
American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: 2-year follow-up assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Osteoarthritis, run by Centre for Orthopaedic Research Alkmaar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative TAR component accuracy (time frame: 2-year follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.