Lateral Approach Versus Anterior Approach in Total Ankle Replacement

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.

Study Overview

• Status: Withdrawn
• Conditions: Ankle Osteoarthritis
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cesar De Cesar Netto, MD; Phone Number: (319) 678-7943; Email: cesar-netto@uiowa.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lateral Approach	Procedure: Total Ankle Replacement; Participants will undergo either lateral approach or anterior approach when having a total ankle replacement
Active Comparator: Anterior Approach	Procedure: Total Ankle Replacement; Participants will undergo either lateral approach or anterior approach when having a total ankle replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	To compare major and minor complications of patients undergoing TAR through lateral and anterior approaches.	6 months post-surgery
Survival	To compare survival rate between the two techniques.	6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot and Ankle Ability Measure	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
PROMIS Global Health	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
PROMIS Depression - Short Form	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
PROMIS Physical Function 8B	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
PROMIS Pain Interference 8A	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
Pain VAS Scale	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
Tampa Scale for Kinesiophobia	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery

Collaborators and Investigators

• Sponsor: John Femino
• Investigators: Principal Investigator: John Femino, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Estimated): July 5, 2022
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 202010410

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