A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System

N/ANot Yet RecruitingNCT07118501

Stryker Trauma and Extremities200 enrolled

Overview

The goal of this study is to demonstrate the safety and performance of the Incompass™ Total Ankle System after surgery over the standard follow-up period. The study will measure improvements in patient-reported information related to quality of life and pain following surgery. In order to do this, medical imaging (i.e. X-Rays, CT scans) which have been taken as part of routine care, will be reviewed. Any additional X-Rays conducted during the period of the research will also be reviewed. The Incompass™ Total Ankle System has been cleared by the Food and Drug Administration (FDA). The products are already in use routinely in ankle replacement surgeries. No part of this study is experimental.

It is anticipated that a total of 200 subjects will be enrolled at up to ten sites over a three year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with a total ankle replacement including imaging (x-rays and or CT scans). The primary endpoint of this study is the 24-month total Ankle Osteoarthritis Scale (AOS) score improvement after index surgery (or Initial Assessment). Secondary endpoints include safety (adverse events, reoperation, and survivorship) as well as performance measures (radiographic assessments, PROMIS Global Health questionnaire, Foot and Ankle Ability Measure \[FAAM\] and Total Ankle Replacement \[TAR\] Satisfaction questionnaires).

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Post Traumatic Arthritis Osteoarthritis Total Ankle Replacement

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The participant must be willing and able to sign a written approved informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC) 2. Participants must be males or non-pregnant females aged 21 years or older at the time of surgery; 3. Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits. 4. The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires. 5. Considered a candidate for total ankle replacement with the Incompass Total Ankle System in accordance with its legally approved Indication for Use (IFU). Exclusion Criteria: 1. Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement; 2. Participant is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results; 3. Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44. 4. Participants who have participated previously in this clinical trial and who have been withdrawn. 5. Participant who is, or will be, inaccessible for follow-up 6. Participant is pregnant or intends to become pregnant during the course of the study. 7. Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation. 8. Participants requiring revision total ankle replacement of the ankle being considered for the study; 9. Participants with a failed previous ankle surgery (e.g., takedown fusion) 10. Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis; 11. Participants with compromised vascularity that would inhibit blood supply to the operative site; 12. Neuropathic arthropathy of the joint; 13. Insufficient bone stock or bone quality that cannot provide adequate support of the device; 14. Participants who have documented or suspected sensitivity to the implant materials. 15. Participants with inadequate neuromuscular status or those having poor skin coverage around the joint, which would make the procedure unjustifiable 16. Participant who routinely place excessive loads on their ankle as caused by activity and/or patient weight, per investigator discretion; or 17. Any mental or neuromuscular disorder that would create an unacceptable risk of failure or complications in postoperative care.

Outcomes

Primary Outcomes

Ankle Osteoarthritis Scale (AOS)

The AOS questionnaire consists of two 9-item subscales: one for pain and one for disability. Each subscale uses a visual analogue scale where patients mark a point on a 100mm horizontal line anchored by "No pain" and "Worst pain imaginable" for pain, or "No difficulty" and "So difficult unable" for disability

Time frame: Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year

Secondary Outcomes

Foot and Ankle Ability Measure (FAAM)

The FAAM has 29 questions and two components that are scored independently: an Activities of Daily Living (ADL) subscale and a Sports subscale. Each subscale is scored from 0 to 100 points, with higher scores representing better function.

Time frame: Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year

PROMIS Scale v1.2- Global Physical Health Score

The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score." The average "TScore" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

Time frame: Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year

PROMIS Scale v1.2- Global Mental Health Score

Time frame: Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year

TAR Satisfaction

Patient satisfaction with the Incompass™ Total Ankle System post-operatively is assessed utilizing a four-point scale: excellent, good, fair and poor.

Time frame: 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year

Radiographic Findings

Radiographic assessment for component loosening and/or subsidence, any osteolysis and/or cyst formation early and through the lifetime of the implant.

Time frame: Baseline, 6 months, 1 year, 2 year, 5 year, 7 year, 10 year.

Safety - Adverse Event

The incidence of device-related Adverse Events by 10 years, as collected and reported by the Investigator

Time frame: Baseline to 10 years postoperative

Safety - Survivorship

The survivorship rate by 10 years, as defined with a Kaplan-Meier survivorship analysis.

Time frame: Baseline to 10 years.