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

Rheumatoid Arthritis Clinical Trial

— Cadence  

Official title:

A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03142958
• Other study ID #: T-CTAS-001
• Status: Suspended
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: July 15, 2024

Study information

• Verified date: February 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 132
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Degenerative Arthritis
• Osteoarthritis
• Post Traumatic Arthritis
• Rheumatoid Arthritis

Intervention

Device:
• Integra Cadence Total Ankle System
Primary or revision on total ankle replacement

Locations

Country	Name	City	State
Canada	Calgary - South Health Campus	Calgary	Alberta
Canada	Providence St. Joseph's and St. Michael's Healthcare	Toronto	Ontario
United States	State University of Ney York - Buffalo	Buffalo	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Duke University	Durham	North Carolina
United States	Rothman Institute	Philadelphia	Pennsylvania
United States	Kaiser Permanente	San Francisco	California
United States	Florida Orthopedic Foot and Ankle Center	Sarasota	Florida
United States	Catholic Health Initiatives	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	OhioHealth Research Institute	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survivorship	Implant survival defined as absence of device removal or revision.	2 years
Secondary	Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline	Relative change of PROMIS PF - Mobility compared to baseline	up to 10 Years
Secondary	Relative change of Range Of Motion (ROM) compared to baseline	Relative change of ROM compared to baseline	up to 10 Years
Secondary	Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline	Relative change of FAAM compared to baseline	up to 10 Years
Secondary	Relative change of Pain compared to baseline	Relative change of Visual Analogue Scale Pain compared to baseline	up to 10 Years
Secondary	Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)	Relative change of SF-36v2 compared to baseline	up to 10 Years
Secondary	Implant Survivorship	Implant survival defined as absence of device removal or revision.	5 and 10 Years