Clinical trial NCT05562154: Lateral Approach Versus Anterior Approach in Total Ankle Replacement
Official title: Lateral Approach Versus Anterior Approach in Total Ankle Replacement: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ankle Osteoarthritis
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Complications
timeFrame: 6 months post-surgery
measure: Survival
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Foot and Ankle Ability Measure
timeFrame: 96 weeks post-surgery
measure: PROMIS Global Health
timeFrame: 96 weeks post-surgery
measure: PROMIS Depression - Short Form
timeFrame: 96 weeks post-surgery
measure: PROMIS Physical Function 8B
timeFrame: 96 weeks post-surgery
measure: PROMIS Pain Interference 8A
timeFrame: 96 weeks post-surgery
measure: Pain VAS Scale
timeFrame: 96 weeks post-surgery
measure: Tampa Scale for Kinesiophobia
timeFrame: 96 weeks post-surgery
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: John Femino, MD
role: PRINCIPAL_INVESTIGATOR
References: