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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P240020 / PAS002 |
| Date Original Protocol Accepted |
09/05/2025
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| Date Current Protocol Accepted |
12/17/2025
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| Study Name |
TOUCH CMC 1 New Enrollment Study
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| Device Name |
TOUCH® CMC 1 Prosthesis
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| Clinical Trial Number(s) |
NCT01954433
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, multi-center, single-arm observational post-approval study (PAS) with hypothesis testing.
The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. The device performance in newly enrolled US patients implanted by US surgeons will be compared to device performance observed within the outside the US (OUS) premarket cohort.
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| Study Population |
US Adult patients requiring surgical intervention for treating 1st CMC joint osteoarthritis that are indicated for the device, do not have any contraindications and who have failed non-conservative treatment.
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| Sample Size |
Minimum of 163 subjects
Up to 8 US sites, with no single site enrolls greater than 25% of subjects
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| Key Study Endpoints |
A composite clinical success (CSS) endpoint will be evaluated at 24 months/2 years post-implantation.
To be considered as a success, a subject must meet all of the following criteria:
Improvement of pain: A clinically meaningful improvement in pain during activities defined as a decrease in the Numerical Rating Scale (NRS) pain score of greater than or equal to 30% on a 10-point scale.
Maintenance or improvement in function: defined by key pinch strength, which is greater than or equal to 85% of the subject’s pre-operative key pinch strength.
Safety: success is defined as freedom from:
o Subsequent 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 will be evaluated through 2 years.
Secondary endpoints will be evaluated through 2 years.
Pain at rest
Pain during activities
Key pinch (kg)
Kapandji index
Brief MHQ
Range of Motion (ROM):
Thumb Metacarpal Flexion
Thumb Metacarpal Radial Abduction
Thumb Metacarpal Palmar Abduction
Thumb length
PROMIS® (Patient-Reported Outcomes Measurement Information System) Upper Extremity Computer Adaptive Test (CAT)
PROMIS® Pain Interference CAT
EQ-5D-5L
EQ-5D-VAS
Return to work (days) in those working at baseline
Patient Satisfaction, including aesthetic
Radiographic endpoints:
Device migration
Osteolysis
Radiolucencies
Fracture
Individual components of the safety endpoint, including SSI(s) and adverse events
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| Follow-up Visits and Length of Follow-up |
Screening/Baseline (within 90 days of surgery)
Surgery
6 weeks -/+ 14 days
3 months -/+ 14 days
12 months -/+ 60 days
24 months -/+ 60 days
Patients are to be consented to 5-years for additional follow-up and evaluation, if necessary.
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