Post-Approval Studies (PAS) Database

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Continued Long-Term Follow-up Study

General
Study Status	Study Pending
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: >21
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

Continued Long-Term Follow-up Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	01/08/2026	01/09/2026	On Time
1 year report	07/10/2026
2 year report	07/10/2027
3 year report	07/09/2028
4 year report	07/09/2029

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background