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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03142958
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Tracking Information
First Submitted Date  ICMJE May 2, 2017
First Posted Date  ICMJE May 8, 2017
Last Update Posted Date February 9, 2022
Actual Study Start Date  ICMJE August 24, 2017
Estimated Primary Completion Date February 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
Implant Survivorship [ Time Frame: 2 years ]
Implant survival defined as absence of device removal or revision.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
  • Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline [ Time Frame: up to 10 Years ]
    Relative change of PROMIS PF - Mobility compared to baseline
  • Relative change of Range Of Motion (ROM) compared to baseline [ Time Frame: up to 10 Years ]
    Relative change of ROM compared to baseline
  • Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline [ Time Frame: up to 10 Years ]
    Relative change of FAAM compared to baseline
  • Relative change of Pain compared to baseline [ Time Frame: up to 10 Years ]
    Relative change of Visual Analogue Scale Pain compared to baseline
  • Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) [ Time Frame: up to 10 Years ]
    Relative change of SF-36v2 compared to baseline
  • Implant Survivorship [ Time Frame: 5 and 10 Years ]
    Implant survival defined as absence of device removal or revision.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)
Official Title  ICMJE A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rheumatoid Arthritis
  • Degenerative Arthritis
  • Post Traumatic Arthritis
Intervention  ICMJE Device: Integra Cadence Total Ankle System
Primary or revision on total ankle replacement
Other Name: Primary Ankle Arthroplasty
Study Arms  ICMJE Integra® Cadence™ Total Ankle System
Intervention: Device: Integra Cadence Total Ankle System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 13, 2019)
132
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2017)
131
Estimated Study Completion Date  ICMJE February 2029
Estimated Primary Completion Date February 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03142958
Other Study ID Numbers  ICMJE T-CTAS-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Smith & Nephew, Inc.
Original Responsible Party Integra LifeSciences Corporation
Current Study Sponsor  ICMJE Smith & Nephew, Inc.
Original Study Sponsor  ICMJE Integra LifeSciences Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy Daniels, MD University of Toronto
PRS Account Smith & Nephew, Inc.
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP