Ankle OsteoarthritisNCT05562154
Lateral Approach Versus Anterior Approach in Total Ankle Replacement
A study testing Total Ankle Replacement in people with Ankle Osteoarthritis, run by John Femino at 1 site in United States.
Trial summary
A minimum of 50 patients with ankle end-stage arthritis will be randomized in two parallel groups for surgery. One group will receive a total ankle replacement through an anterior approach and the other group a total ankle replacement via a lateral approach. 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?
- Total Ankle Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 14 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Individuals must be older than 18 and younger than 90 years of age, both genders.
- Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery.
- Clinical and radiographical clinical diagnosis of ankle arthritis.
- Surgical planning of total ankle replacement.
Who cannot join
- Previous surgery for total ankle replacement or ankle arthrodesis.
- History or documented evidence of autoimmune or peripheral vascular diseases.
- History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, seronegative, connective, etc.);
- Any condition that represents a contraindication of the proposed therapies.
- Any physical or social limitation that makes the protocol continuation unviable.
- Impossibility or incapacity to sign the informed Consent Form.
Show all 12Show fewer
- Presence of infectious process (superficial on the skin and cellular tissue, or deep in the bone) in the region to be treated.
- Pregnancy.
- Clinical and imaging diagnosis of untreated osteoporosis.
- Serum vitamin D levels below 20ng/ml.
- Non-palpable anterior or posterior tibial pulse; or abnormal capillary filling.
- Tumor lesions (primary or secondary tumors).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
About this study
Official title: Lateral Approach Versus Anterior Approach in Total Ankle Replacement: A Randomized Clinical Trial
A minimum of 50 patients with ankle end-stage arthritis will be randomized in two parallel groups for surgery. One group will receive a total ankle replacement through an anterior approach and the other group a total ankle replacement via a lateral approach. Patients will be evaluated for a mean follow-up of two years in terms of complications, implant survival and functional results. One of the primary objectives of the study is analyzing the safety of the lateral and anterior approaches for total ankle replacement.
Read the detailed description
A minimum of 50 patients with ankle end-stage arthritis will be randomized in two parallel groups for surgery. One group will receive a total ankle replacement through an anterior approach and the other group a total ankle replacement via a lateral approach. Patients will be evaluated for a mean follow-up of two years in terms of complications, implant survival and functional results. One of the primary objectives of the study is analyzing the safety of the lateral and anterior approaches for total ankle replacement.
The anterior approach uses an interval between the anterior tibial tendon and the extensor digitorum longus tendon to reach the joint. The anterior tibial artery and the deep peroneal nerve must be identified and protected. Once the ankle is reached, the joint is roughly prepared and the cutting guides for the implants are inserted. The position is checked, and the size of the prosthesis is determined. There are several commercial prostheses designed for this approach, although we decided to use the Infinity™ Total Ankle System (Stryker Medical®) to minimize bias. After alignment examination, the implants are inserted, the planes are closed, and the wound is covered. The patient is placed in a cast for three weeks and starts weight-bearing in a boot after this period, using it for three more weeks.
The lateral approach utilizes an incision over the posterior aspect of the fibula. The lateral malleolus is osteotomized 1.5cm proximal to the joint and reflected distally to provide access to the articulation. An external frame is placed around the limb that supplies guidance for the prosthesis cuts. The sizing and position are determined and a Trabecular Metal Total Ankle™ (ZimmerBiomet®) is placed, the only available implant for the lateral approach. The fibula is reduced and fixed using a low profile anatomical lateral plate and screws. Planes are closed, the wound protected, and a cast placed. The post-operative carry is the same as the anterior approach.
Weight bearing CT (WBCT) scans will be used to evaluate outcomes. WBCT is the standard of care for the preoperative and postoperative assessment of patients undergoing total ankle replacement in our institution. Many secondary outcomes will be also evaluated through WBCT since they can better depict alignment, predict failure and diagnose complications (subsidence, cysts). No extra WBCT will be performed other than what we normally do for patients.
Randomization will be performed previously at the beginning of the study and will be performed by an outside researcher. Allocation will happen during surgery scheduling.
- Conditions
- Ankle Osteoarthritis
- Being tested
- Total Ankle Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Ankle ReplacementProcedure or surgery
Participants will undergo either lateral approach or anterior approach when having a total ankle replacement
| Study group | Role | What they receive |
|---|---|---|
| Lateral Approach | Active comparator | Not described Receives: Procedure: Total Ankle Replacement |
| Anterior Approach | Active comparator | Not described Receives: Procedure: Total Ankle Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
To compare major and minor complications of patients undergoing TAR through lateral and anterior approaches.
Measured: 6 months post-surgery
Survival
To compare survival rate between the two techniques.
Measured: 6 months post-surgery
Secondary outcomes (7)
Foot and Ankle Ability Measure
To compare patient reported outcomes (PROs) between the two groups.
Measured: 96 weeks post-surgery
PROMIS Global Health
To compare patient reported outcomes (PROs) between the two groups.
Measured: 96 weeks post-surgery
PROMIS Depression - Short Form
To compare patient reported outcomes (PROs) between the two groups.
Measured: 96 weeks post-surgery
PROMIS Physical Function 8B
To compare patient reported outcomes (PROs) between the two groups.
Measured: 96 weeks post-surgery
PROMIS Pain Interference 8A
To compare patient reported outcomes (PROs) between the two groups.
Measured: 96 weeks post-surgery
Pain VAS Scale
To compare patient reported outcomes (PROs) between the two groups.
Measured: 96 weeks post-surgery
Tampa Scale for Kinesiophobia
To compare patient reported outcomes (PROs) between the two groups.
Measured: 96 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start5 Jul 2022 (estimated)
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Why it stopped: PI left institution and successor no longer interested in topic.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Femino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Femino, University of Iowa
- Investigators
- John Femino, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562154
- Sponsor's protocol ID
- 202010410
- Status last verified
- Dec 2023
- First submitted
- 25 Aug 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Approach Versus Anterior Approach in Total Ankle Replacement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05562154
- Acronym / sponsor ID
- 202010410
- Conditions
- Ankle Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution and successor no longer interested in topic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- John FeminoUniversity, hospital or other
- Study start
- 5 Jul 2022 (estimated)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 30 Sep 2022 (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.
A minimum of 50 patients with ankle end-stage arthritis will be randomized in two parallel groups for surgery. One group will receive a total ankle replacement through an anterior approach and the other group a total ankle replacement via a lateral approach. Patients will be evaluated for a mean follow-up of two years in terms of complications, implant survival and functional results. One of the primary objectives of the study is analyzing the safety of the lateral and anterior approaches for total ankle replacement.
Detailed description
A minimum of 50 patients with ankle end-stage arthritis will be randomized in two parallel groups for surgery. One group will receive a total ankle replacement through an anterior approach and the other group a total ankle replacement via a lateral approach. Patients will be evaluated for a mean follow-up of two years in terms of complications, implant survival and functional results. One of the primary objectives of the study is analyzing the safety of the lateral and anterior approaches for total ankle replacement.
The anterior approach uses an interval between the anterior tibial tendon and the extensor digitorum longus tendon to reach the joint. The anterior tibial artery and the deep peroneal nerve must be identified and protected. Once the ankle is reached, the joint is roughly prepared and the cutting guides for the implants are inserted. The position is checked, and the size of the prosthesis is determined. There are several commercial prostheses designed for this approach, although we decided to use the Infinity™ Total Ankle System (Stryker Medical®) to minimize bias. After alignment examination, the implants are inserted, the planes are closed, and the wound is covered. The patient is placed in a cast for three weeks and starts weight-bearing in a boot after this period, using it for three more weeks.
The lateral approach utilizes an incision over the posterior aspect of the fibula. The lateral malleolus is osteotomized 1.5cm proximal to the joint and reflected distally to provide access to the articulation. An external frame is placed around the limb that supplies guidance for the prosthesis cuts. The sizing and position are determined and a Trabecular Metal Total Ankle™ (ZimmerBiomet®) is placed, the only available implant for the lateral approach. The fibula is reduced and fixed using a low profile anatomical lateral plate and screws. Planes are closed, the wound protected, and a cast placed. The post-operative carry is the same as the anterior approach.
Weight bearing CT (WBCT) scans will be used to evaluate outcomes. WBCT is the standard of care for the preoperative and postoperative assessment of patients undergoing total ankle replacement in our institution. Many secondary outcomes will be also evaluated through WBCT since they can better depict alignment, predict failure and diagnose complications (subsidence, cysts). No extra WBCT will be performed other than what we normally do for patients.
Randomization will be performed previously at the beginning of the study and will be performed by an outside researcher. Allocation will happen during surgery scheduling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral Approach | Active comparator | Procedure: Total Ankle Replacement |
| Anterior Approach | Active comparator | Procedure: Total Ankle Replacement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals must be older than 18 and younger than 90 years of age, both genders.
- Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery.
- Clinical and radiographical clinical diagnosis of ankle arthritis.
- Surgical planning of total ankle replacement.
Key exclusion criteria (12 listed)
- Previous surgery for total ankle replacement or ankle arthrodesis.
- History or documented evidence of autoimmune or peripheral vascular diseases.
- History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, seronegative, connective, etc.);
- Any condition that represents a contraindication of the proposed therapies.
- Any physical or social limitation that makes the protocol continuation unviable.
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 |
|---|---|---|
| Total Ankle ReplacementParticipants will undergo either lateral approach or anterior approach when having a total ankle replacement | Procedure or surgery | Anterior Approach, Lateral Approach |
Primary outcome
Complications
Time frame: 6 months post-surgery
To compare major and minor complications of patients undergoing TAR through lateral and anterior approaches.
Survival
Time frame: 6 months post-surgery
To compare survival rate between the two techniques.
7 secondary outcomes
Foot and Ankle Ability Measure
Time frame: 96 weeks post-surgery
PROMIS Global Health
Time frame: 96 weeks post-surgery
PROMIS Depression - Short Form
Time frame: 96 weeks post-surgery
PROMIS Physical Function 8B
Time frame: 96 weeks post-surgery
PROMIS Pain Interference 8A
Time frame: 96 weeks post-surgery
Pain VAS Scale
Time frame: 96 weeks post-surgery
Tampa Scale for Kinesiophobia
Time frame: 96 weeks post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Ankle Osteoarthritis
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Diagnostic Accuracy of Triphasic Bone Scan and SPECT/CT in Foot and Ankle Osteoarthritis
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UK Infinity, Post-Market Clinical Follow-up Study
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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.
John Femino, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Ankle Replacement in people with Ankle Osteoarthritis, run by John Femino at 1 site in United States.
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 12 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: withdrawn, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Complications (time frame: 6 months post-surgery). The study lists 2 primary outcomes in all. 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 20 Dec 2023.