Degenerative Arthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Brief summary
This study will evaluate the long term performance and safety data for the Cadence™ Total Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
Interventions
DEVICEImplantation of Integra Cadence Total Ankle System
Primary Ankle Arthroplasty
Sponsors
Smith & Nephew, Inc.
Smith & Nephew Orthopaedics AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will be included if he/she: 1. Is \> 18 years of age. 2. Is skeletally mature. 3. Qualifies for primary TAR per the surgeon and has a diagnosis of one of the following: primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), or systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis). 4. Is suitable for TAR with CTAS per the study surgeon based on the product indication and having considered deformity, stability, bone quality, soft- tissue envelope, and neurovascular status. 5. Is willing and able to cooperate in the required post-operative therapy. 6. Is willing and able to complete scheduled follow-up visits, evaluations, and questionnaires as described in the Informed Consent or Information Letter and Data Transfer Authorization Form, as applicable. 7. Reads, understands and signs the Ethical Committee approved Informed Consent or Information Letter and Data Transfer Authorization Form, as applicable
Exclusion criteria
Subjects will be excluded from the study if he/she: 1. Is Morbidly Obese (defined by BMI \> 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight). 2. Is an active nicotine user (smoking, chewing, smokeless tobacco, patch) and unwilling to cease nicotine use within 1 month prior to surgery, and 2 months post-surgery. 3. Has one of the following conditions, which could compromise the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological (Charcot's Arthropathy) or vascular disease, loss of musculature or neuromuscular compromise. 4. Has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection. 5. Continues on long-term medication, which may compromise bone stock (e.g. undergoing immunosuppressive therapy, long-term steroids) and is unable to cease medication usage from 3 weeks prior to surgery to 3 weeks post-surgery. 6. Has a condition that may impair proper wound healing (e.g., poor soft tissue envelope). 7. Had previous ankle surgery and/or injury that has adversely affected the anklebone stock. 8. Has had or is scheduled to have contralateral TAR surgery. 9. Is pregnant or plans to become pregnant during the follow up period. 10. Has a metabolic disorder or disease that may compromise bone quality (e.g. arthrogryposis etc.), physiological or anatomical anomalies, and/or malignancy/local bone tumors. 11. Has severe avascular necrosis of the talus/tibia. 12. Has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy). 13. Has a known sensitivity or allergic reaction to one or more of the implanted materials. 14. Is a poor candidate for general anesthesia. 15. Is a prisoner, mentally incompetent or unable to understand what participation in this study entails, a known alcohol or drug abuser, or anticipated to be non- compliant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship at 2 Years | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship at 5 Years and 10 Years | 5 years and 10 years | 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. |
| Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Visual Analogue Scale (VAS) Pain Score: Resting | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Visual Analogue Scale (VAS) Pain Score: Activity | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): Physical Functioning | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Physical Health | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Emotional Problems | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): Energy/Fatigue | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): Emotional Well-being | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): Social Functioning | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): Pain | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): General Health | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): Physical Component Score | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Short Form-36 Version 2 Health Survey (SF-36v2): Mental Component Score | Baseline, 3 months, 6 months, 1 year, 2 years, 5 years | 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). |
| Radiographic Success | 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years | 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 |
| Radiographic Assessment: Ankle Dorsiflexion and Plantarflexion Range of Motion | Baseline, 1 year, 2 years | Range of motion measurements for ankle dorsiflexion and ankle plantarflexion in degrees were derived from radiographs in positions of maximum plantarflexion and dorsiflexion. |
| Radiographic Assessment: Tibiotalar Range of Motion | Baseline, 1 year, 2 years | 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. |
Countries
Belgium, Canada, France, Spain, United Kingdom
Participant flow
Pre-assignment details
Of the 65 participants enrolled, 4 participants were discontinued from the study due to screening failures with a total of 61 participants starting the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 11.9 |
| Body Mass Index (BMI) | 28.5 kg/m^2 STANDARD_DEVIATION 4.4 |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 61 |
| other Total, other adverse events | 12 / 61 |
| serious Total, serious adverse events | 19 / 61 |
Outcome results
None listed