Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)

Suspended

• Conditions: Rheumatoid Arthritis; Degenerative Arthritis; Post Traumatic Arthritis
• Interventions: Device: Integra Cadence Total Ankle System

• Registration Number: NCT03142958
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-08
• Study Start: 2017-08-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• The patient is skeletally mature.
• The patient qualifies for primary Total Ankle Replacement (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).
• The patient is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent.
• The patient reads, understands and signs the Institutional Review Board (IRB) approved Informed Consent.

Exclusion Criteria

• The patient is Morbidly Obese (defined by Body Mass Index (BMI) > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
• The patient 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.
• The patient has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
• The patient has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
• The patient is pregnant or plans to become pregnant during the follow up period.
• The patient 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.
• The patient has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
• The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Integra® Cadence™ Total Ankle System	Integra Cadence Total Ankle System	-

Primary Outcome Measures

Name	Time	Method
Implant Survivorship	2 years	Implant survival defined as absence of device removal or revision.

Secondary Outcome Measures

Name	Time	Method
Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline	up to 10 Years	Relative change of FAAM compared to baseline
Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)	up to 10 Years	Relative change of SF-36v2 compared to baseline
Relative change of Pain compared to baseline	up to 10 Years	Relative change of Visual Analogue Scale Pain compared to baseline
Implant Survivorship	5 and 10 Years	Implant survival defined as absence of device removal or revision.
Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline	up to 10 Years	Relative change of PROMIS PF - Mobility compared to baseline
Relative change of Range Of Motion (ROM) compared to baseline	up to 10 Years	Relative change of ROM compared to baseline

Trial Locations

Locations (11)

State University of Ney York - Buffalo; 🇺🇸 Buffalo, New York, United States

OhioHealth Research Institute; 🇺🇸 Westerville, Ohio, United States

Kaiser Permanente; 🇺🇸 San Francisco, California, United States

Florida Orthopedic Foot and Ankle Center; 🇺🇸 Sarasota, Florida, United States

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Catholic Health Initiatives; 🇺🇸 Seattle, Washington, United States

Providence St. Joseph's and St. Michael's Healthcare; 🇨🇦 Toronto, Ontario, Canada

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Calgary - South Health Campus; 🇨🇦 Calgary, Alberta, Canada

Duke University; 🇺🇸 Durham, North Carolina, United States