Implant survivorship determined by the percentage of participants with survival of the device. Successful device survival was defined as absence of device removal or revision.

The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified.

Implant survivorship at 5 years and 10 years was determined by the percentage of participants with device survival. Survivorship was measured using a Kaplan-Meier survival estimate with survival defined as absence of device removal or revision.

The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The PROMIS - Physical Function and Mobility score consisted of 15 components on a 5-point Likert scale. Responses were combined to produce a score that ranged from 0 to 100 where higher values represented higher mobility (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale scored 21 components on a 5-point Likert scale. Score totals ranged from 0 to 84 and were transformed to percentage scores with 100 representing no dysfunction (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

A Visual Analogue Scale (VAS) assessment was used to rate ankle pain while resting. The participant would indicate the level of pain by placing a vertical mark on a 100mm scale. Scores ranged from 0 to 100 with higher scores indicating a higher level of pain (i.e., a higher score was a worse outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

A Visual Analogue Scale (VAS) assessment was used to rate ankle pain while during activity. The participant would indicate the level of pain by placing a vertical mark on a 100mm scale. Scores ranged from 0 to 100 with higher scores indicating a higher level of pain (i.e., a higher score was a worse outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Physical Functioning domain focused on limitations in daily activities like running, climbing stairs, bending, or walking. Scores ranged from 0 to 100 with lower scores indicating greater physical disability (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Role Limitations Due to Physical Health domain focused on limitations in work or other regular daily activities as a result of their physical health. Scores ranged from 0 to 100 with lower scores indicating greater limitation (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Role Limitations Due to Emotional Problems domain focused on limitations in work or other regular daily activities as a result of any emotional problems such as feeling depressed or anxious. Scores ranged from 0 to 100 with lower scores indicating greater limitation (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Energy/Fatigue domain focused on feelings of energy, tiredness, and being worn out over the past four weeks. Scores ranged from 0 to 100 with lower scores indicating less energy and more fatigue (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Emotional Well-being domain focused on feelings of their mental health over the past four weeks. Scores ranged from 0 to 100 with lower scores indicating poor emotional well-being (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Social Functioning domain focused on how physical health or emotional problems interfered with their social activities (like visiting with friends, relatives, etc.). Scores ranged from 0 to 100 with lower scores indicating greater disfunction (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Pain domain focused on how much pain affected daily activities over the last four weeks. Scores ranged from 0 to 100 with lower scores indicating more pain (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The General Health domain focused on perception of overall health and health change over time. Scores ranged from 0 to 100 with lower scores indicating worse health (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Physical Component score combined scores from the Physical Functioning, Role Limitations Due to Physical Health, Pain, and General Health domains. Scores ranged from 0 to 100 with lower scores indicating worse physical health (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Physical Component score combined scores from the Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, and Social Functioning domains. Scores ranged from 0 to 100 with lower scores indicating worse mental health (i.e., a higher score was a better outcome).

The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

The number of participants with radiographic success were categorized as either 'Fail' or 'Success'. Success was defined as absence of implant radiolucency, subsidence, tilting, and/or migration with failure specifically defined as occurring if:

1. ≥3 of the 20 radiolucency zones had >4mm in width, OR
2. device tilting = present, OR
3. device subsidence (tibial OR talar) = >4mm, OR
4. device migration (tibial OR talar) = >4mm

The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.

Range of motion measurements for ankle dorsiflexion and ankle plantarflexion in degrees were derived from radiographs in positions of maximum plantarflexion and dorsiflexion.

The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified.

Range of motion measurements were derived from radiographs in positions of maximum plantarflexion and dorsiflexion. Tibiotalar range of motion in degrees was calculated as the difference between the ankle dorsiflexion and ankle plantarflexion angles.

The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified.