Rheumatoid Arthritis Clinical Trial
— CadenceOfficial 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
Verified date | February 2024 |
Source | Smith & Nephew, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Smith & Nephew, Inc. |
United States, Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |