Lateral Approach Versus Anterior Approach in Total Ankle Replacement
Primary Purpose
Ankle Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Ankle Replacement
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Osteoarthritis
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).
Sites / Locations
- University of Iowa Hospitals & ClinicsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lateral Approach
Anterior Approach
Arm Description
Outcomes
Primary Outcome Measures
Complications
To compare major and minor complications of patients undergoing TAR through lateral and anterior approaches.
Survival
To compare survival rate between the two techniques.
Secondary Outcome Measures
Foot and Ankle Ability Measure
To compare patient reported outcomes (PROs) between the two groups.
PROMIS Global Health
To compare patient reported outcomes (PROs) between the two groups.
PROMIS Depression - Short Form
To compare patient reported outcomes (PROs) between the two groups.
PROMIS Physical Function 8B
To compare patient reported outcomes (PROs) between the two groups.
PROMIS Pain Interference 8A
To compare patient reported outcomes (PROs) between the two groups.
Pain VAS Scale
To compare patient reported outcomes (PROs) between the two groups.
Tampa Scale for Kinesiophobia
To compare patient reported outcomes (PROs) between the two groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05562154
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lateral Approach
Arm Type
Active Comparator
Arm Title
Anterior Approach
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Total Ankle Replacement
Intervention Description
Participants will undergo either lateral approach or anterior approach when having a total ankle replacement
Primary Outcome Measure Information:
Title
Complications
Description
To compare major and minor complications of patients undergoing TAR through lateral and anterior approaches.
Time Frame
6 months post-surgery
Title
Survival
Description
To compare survival rate between the two techniques.
Time Frame
6 months post-surgery
Secondary Outcome Measure Information:
Title
Foot and Ankle Ability Measure
Description
To compare patient reported outcomes (PROs) between the two groups.
Time Frame
96 weeks post-surgery
Title
PROMIS Global Health
Description
To compare patient reported outcomes (PROs) between the two groups.
Time Frame
96 weeks post-surgery
Title
PROMIS Depression - Short Form
Description
To compare patient reported outcomes (PROs) between the two groups.
Time Frame
96 weeks post-surgery
Title
PROMIS Physical Function 8B
Description
To compare patient reported outcomes (PROs) between the two groups.
Time Frame
96 weeks post-surgery
Title
PROMIS Pain Interference 8A
Description
To compare patient reported outcomes (PROs) between the two groups.
Time Frame
96 weeks post-surgery
Title
Pain VAS Scale
Description
To compare patient reported outcomes (PROs) between the two groups.
Time Frame
96 weeks post-surgery
Title
Tampa Scale for Kinesiophobia
Description
To compare patient reported outcomes (PROs) between the two groups.
Time Frame
96 weeks post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesar De Cesar Netto, MD
Phone
(319) 678-7943
Email
cesar-netto@uiowa.edu
Facility Information:
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar de Cesar Netto
12. IPD Sharing Statement
Plan to Share IPD
No
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Lateral Approach Versus Anterior Approach in Total Ankle Replacement
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