Lateral Approach Versus Anterior Approach in Total Ankle Replacement

NCT05562154 | Withdrawn

• 1 other identifier: 202010410
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Foot and Ankle Ability Measure

  96 weeks post-surgery

• PROMIS Global Health

  96 weeks post-surgery

• PROMIS Depression - Short Form

  96 weeks post-surgery

• PROMIS Physical Function 8B

  96 weeks post-surgery

• PROMIS Pain Interference 8A

  96 weeks post-surgery

Study Arms (2)

Lateral Approach

ACTIVE COMPARATOR

Procedure: Total Ankle Replacement

Anterior Approach

ACTIVE COMPARATOR

Procedure: Total Ankle Replacement

Interventions

Total Ankle Replacement PROCEDURE

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

Anterior Approach; Lateral Approach

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• John Femino: lead

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Ankle

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• John Femino, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 30, 2022
• Study Start: July 5, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)