ClinicalTrials.gov

History of Changes for Study: NCT03142958
Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE) (Cadence)
Latest version (submitted February 7, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 5, 2017 None (earliest Version on record)
2 August 24, 2017 Study Status and Contacts/Locations
3 August 25, 2017 Contacts/Locations and Study Status
4 December 18, 2017 Arms and Interventions, Study Status and Contacts/Locations
5 January 22, 2019 Contacts/Locations and Study Status
6 April 9, 2019 Recruitment Status, Study Status and Contacts/Locations
7 August 29, 2019 Study Status
8 September 13, 2019 Study Design and Study Status
9 November 5, 2020 Study Status
10 May 24, 2021 Study Status, Sponsor/Collaborators and Study Identification
11 February 7, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03142958
Submitted Date:  May 5, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: T-CTAS-001
Brief Title: Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE) (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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2017
Overall Status: Recruiting
Study Start: May 2, 2017
Primary Completion: May 2020 [Anticipated]
Study Completion: May 2028 [Anticipated]
First Submitted: May 2, 2017
First Submitted that
Met QC Criteria:
May 5, 2017
First Posted: May 8, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
May 5, 2017
Last Update Posted: May 8, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Integra LifeSciences Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Rheumatoid Arthritis
Degenerative Arthritis
Post Traumatic Arthritis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 131 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Integra® Cadence™ Total Ankle System
Device: Integra Cadence Total Ankle Sysyem
Primary or revision on total ankle replacement
Other Names:
  • Primary Ankle Arthroplasty
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Implant Survivorship
[ Time Frame: 2 years ]

Implant survival defined as absence of device removal or revision.
Secondary Outcome Measures:
1. 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
2. Relative change of Range Of Motion (ROM) compared to baseline
[ Time Frame: up to 10 Years ]

Relative change of ROM compared to baseline
3. 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
4. Relative change of Pain compared to baseline
[ Time Frame: up to 10 Years ]

Relative change of Visual Analogue Scale Pain compared to baseline
5. 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
6. Implant Survivorship
[ Time Frame: 5 and 10 Years ]

Implant survival defined as absence of device removal or revision.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Jeremy L West
Telephone: 609-936-5539
Email: jeremy.west@integralife.com
Central Contact Backup: Andrew Tummon
Telephone: 609-936-5490
Email: andrew.tummon@integralife.com
Study Officials: Timothy Daniels, MD
Principal Investigator
University of Toronto
Locations: United States, Ohio
OhioHealth Research Institute
[Recruiting]
Westerville, Ohio, United States, 43082
United States, Pennsylvania
Rothman Institute
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 49525
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services