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WithdrawnNCT05562154Updated Dec 20, 2023

Lateral Approach Versus Anterior Approach in Total Ankle Replacement

An interventional study of Total Ankle Replacement in Ankle Osteoarthritis, sponsored by John Femino. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by John Femino · Not applicable, Interventional, and Treatment

Why this study was withdrawn
PI left institution and successor no longer interested in topic.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Ankle Osteoarthritis

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

Browse Osteoarthritis studies →

Lead sponsor

John Femino is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Lateral Approach

    Procedure: Total Ankle Replacement

  • Active comparator
    Anterior Approach

    Procedure: Total Ankle Replacement

Interventions

  • ProcedureTotal Ankle Replacement

    Participants will undergo either lateral approach or anterior approach when having a total ankle replacement

06

What researchers measure

Primary outcomes

  1. Complications

    To compare major and minor complications of patients undergoing TAR through lateral and anterior approaches.

    Time frame: 6 months post-surgery

  2. Survival

    To compare survival rate between the two techniques.

    Time frame: 6 months post-surgery

Secondary outcomes

  1. Foot and Ankle Ability Measure

    To compare patient reported outcomes (PROs) between the two groups.

    Time frame: 96 weeks post-surgery

  2. PROMIS Global Health

    To compare patient reported outcomes (PROs) between the two groups.

    Time frame: 96 weeks post-surgery

  3. PROMIS Depression - Short Form

    To compare patient reported outcomes (PROs) between the two groups.

    Time frame: 96 weeks post-surgery

  4. PROMIS Physical Function 8B

    To compare patient reported outcomes (PROs) between the two groups.

    Time frame: 96 weeks post-surgery

  5. PROMIS Pain Interference 8A

    To compare patient reported outcomes (PROs) between the two groups.

    Time frame: 96 weeks post-surgery

  6. Pain VAS Scale

    To compare patient reported outcomes (PROs) between the two groups.

    Time frame: 96 weeks post-surgery

  7. Tampa Scale for Kinesiophobia

    To compare patient reported outcomes (PROs) between the two groups.

    Time frame: 96 weeks post-surgery

07

Study locations

1 site
  • University of Iowa Hospitals & Clinics
    Iowa City, Iowa 52242, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05562154
Lead sponsor
John Femino
Responsible party
John Femino (Principal Investigator, University of Iowa) — Sponsor-investigator
First posted
Sep 30, 2022
Start date
Jul 5, 2022 (estimated)
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023
Last update
Dec 20, 2023

Study contacts

John Femino, MD
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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