Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)

Rheumatoid Arthritis Clinical Trial

Official title:

An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691868
• Other study ID #: CR16-004
• Status: Recruiting
• Start date: April 8, 2019
• Est. completion date: September 30, 2031

Study information

• Verified date: February 2024
• Source: Exactech
• Contact: Rachael Craig
• Phone: 352-377-1140
• Email: rachael.craig[@]exac.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 30, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patient is indicated for total ankle arthroplasty

• Patient is at least 21 years of age

• Patient is likely to be available for follow-up out to 10 years

• Patient is willing to participate by complying with pre- and postoperative visit requirements

• Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

• Patient with excessive bone loss at the ankle joint site

• Patient with severe osteoporosis

• Patient with complete talar avascular necrosis

• Patient with active osteomyelitis

• Patient with infection at the ankle site or infection at distant sites that could migrate to the ankle

• Patient with sepsis

• Patient with vascular deficiency in the involved limb

• Pateint with neuropathic joints

• Patient with neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing

• Patient with poor soft tissue coverage around the ankle

• Patient with Charcot arthropathy

• Previsous ankle arthrodesis with excision of the malleoli

• Excessive loads as cuased by activity or patient weight - per investigator discretion

• Skeletally immature patients (patient is less than 21 years if age at time of surgery)

• Patient with dementia

• Patient with known metal allergies

• Patients who are unwilling to provide informed consent

• Patients who are unlikely to be available for follow-up out to 10 years

• Patients who are not deemed suitable candidates for the subject device

• Patient is pregnant

Related Conditions & MeSH terms

• Arthritis
• Prosthesis Failure
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	Santa Cruz De Tenerife
Switzerland	SWISS ORTHO CENTER Pain Clinic Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Countries where clinical trial is conducted

Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOFAS	American Orthopedic Foot and Ankle Society Score (AOFAS) - Questionaire on pain (40 points), function (45 points) , and alignment (15 points) - 100 points score where 100 indicates a healthy midfoot	Through study completion, an average of 1 per year
Primary	SMFA	Short Musculoskeletal Function Assessment (SMFA) Score - 46 items Patient questionnaire divided into two sections: 34 questions on patients function assessment and 12 questions covering how bothered patients are by their symptoms where 1 indicates no problems/no difficulty/ not bothered and 5 indicates unable to do/symptoms all the time/being greatly bothered	Through study completion, an average of 1 per year
Primary	SF-36	Short Form Health Survey (SF-36) Score - 36-item patient-reproted survey of patient health - It consists on 8 scales: Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each scale is transformed into a 0-100 scale where the lower score indicates the more disability and the higher score the lest disability	Through study completion, an average of 1 per year
Primary	Sports Frequency Score	Sports Frequency Score - Level of sport activity in leisure time where 0 indicates "no sports activity" and 4 indicates "professional level of sports activity, elite athlete	Through study completion, an average of 1 per year
Primary	VAS Pain score and Patient Satisfaction	Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity	Through study completion, an average of 1 per year