|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P240020 / PAS001 |
| Date Original Protocol Accepted |
09/05/2025
|
| Date Current Protocol Accepted |
09/05/2025
|
| Study Name |
Continued Long-Term Follow-up Study
|
| Device Name |
TOUCH® CMC 1 Prosthesis
|
| Clinical Trial Number(s) |
NCT01954433
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Study Design and Objective(s) A descriptive prospective, single-center, single-arm study design.
To evaluate the 5-year long-term safety and effectiveness of the TOUCH CMC 1 Prosthesis.
|
| Study Population |
Study Population Enrollment of the patients included in the original PMA cohort (Touch Cohort Swiss study), who are evaluable for the long term 5 year follow up, which includes all 103 remaining patients, from the original 149 patients.
Supplemental analysis will evaluate:
- Retrospective PMCF 5-Year Study: N=74 patients (82 devices)
- Published Falaise et al. 2025: N=57 patients (61 devices)
|
| Sample Size |
103
|
| Key Study Endpoints |
Study Endpoints Primary endpoints:
A Year 5 composite clinical success (CCS) primary endpoint will be employed. To be a success, a subject must meet all of the following criteria:
• Improvement of pain: A clinically meaningful improvement in pain defined as a decrease in the pain score of = 30% on a 10-point scale.
• Maintenance or improvement in function: defined by key pinch strength which is = 85% of the subject’s pre-operative key pinch strength.
• Safety: success is defined as freedom from:
o Subsequent secondary surgical interventions (SSI) (i.e., reoperation, revision, removal of any study component, or supplemental fixations) on the study carpometacarpal joint, or
Serious, device- or procedure-related adverse events.
Secondary endpoints:
• Pain evolution (% change), as measured by either Numerical Rating Scale (NRS) or Visual Analog Scale (VAS) on a 10-point scale
• Key pinch strength (kg) evolution
• Kapandji index
• Patient satisfaction via brief Michigan Hand Outcomes Questionnaire (bMHQ)
• Return to work time
• Radiographic success – investigators will make best efforts to obtain 5 years post-operative radiographs for all enrolled subjects: absence of device migration, osteolysis, radiolucencies or fracture
Individual components of the CCS including need for revision surgery and serious, device-related adverse events¿
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
The report tracks three (3) cohorts with extended follow-up: (1) The TOUCH® Swiss Cohort: N=90, 5-year follow-up; (2) Supplemental PMCF Set: N=82, 5-year follow-up; and (3) Supplemental Falaise Set: N=57, 6.5-year follow-up. These are compared against the original PMA study (N=149, 2-year follow-up).
The Implant Survival Rate was high across all cohorts (93.9% to 100% at 5+ years).
Revisions/Removals: 4 events at 2 years; only 2 additional events between 2-5 years.
Radiographic Findings: Low rates maintained or improved (migration 0%, radiolucent lines decreased from 21.2% to 13%, no new fractures).
Effectiveness Results:
Consistently low pain scores maintained through 5 years, with mean scores generally unchanged from 2-year timepoints
Key pinch strength and success rates (85-91.9%) remained acceptable, though numerically lower in some supplemental cohorts.
Kapandji Index scores showed maintained or improved performance, particularly in supplemental cohorts.
|
| Actual Number of Patients Enrolled |
TOUCH® Swiss Cohort: 103 remaining subjects
|
| Actual Number of Sites Enrolled |
Already occurred during the premarket study
|
| Patient Follow-up Rate |
Follow-up rate is 87% (90/103)
|
