Lateral Approach Versus Anterior Approach in Total Ankle Replacement

Ankle Osteoarthritis Clinical Trial

Official title:

Lateral Approach Versus Anterior Approach in Total Ankle Replacement: A Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05562154
• Other study ID #: 202010410
• Status: Withdrawn
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: December 14, 2023

Study information

• Verified date: December 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Osteoarthritis

Intervention

Procedure:
• Total Ankle Replacement
Participants will undergo either lateral approach or anterior approach when having a total ankle replacement

Locations

Country	Name	City	State
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
John Femino

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	To compare major and minor complications of patients undergoing TAR through lateral and anterior approaches.	6 months post-surgery
Primary	Survival	To compare survival rate between the two techniques.	6 months post-surgery
Secondary	Foot and Ankle Ability Measure	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
Secondary	PROMIS Global Health	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
Secondary	PROMIS Depression - Short Form	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
Secondary	PROMIS Physical Function 8B	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
Secondary	PROMIS Pain Interference 8A	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
Secondary	Pain VAS Scale	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery
Secondary	Tampa Scale for Kinesiophobia	To compare patient reported outcomes (PROs) between the two groups.	96 weeks post-surgery