N/A
N=95
Comparison of ARPE Prosthesis With the Literature
Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01904019 ↗Enrolled (actual)
95
Serious AEs
17.9%
Results posted
Aug 2021
Primary outcome: Primary: Grip Strength — 17.8; 23.4; 24.7; 25 kg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Grip Strength |
17.8; 23.4; 24.7; 25 | — |
| PRIMARY Key Pinch Strength |
3.6; 5.8; 5.5; 5.9 | — |
| PRIMARY Tip Pinch Strength |
2.7; 4.5; 4.6; 4.5 | — |
| PRIMARY VAS Pain |
59.3; 11.1; 10.3; 7.1 | — |
| SECONDARY Motion - ROM Measurement - Radial Abduction |
41.5; 53.1; 47.5; 43.8 | — |
| SECONDARY Motion - ROM Measurement - Palmar Abduction |
43.2; 48.1; 47.8; 43.4 | — |
| SECONDARY EQ-5D - Health Status Score |
0.4; 0.8; 0.8; 0.8 | — |
| SECONDARY EQ-5D - VAS Score |
72.7; 74.1; 77.9; 76.2 | — |
| SECONDARY Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis |
0; 0; 0 | — |
| SECONDARY Hand Function: DASH Questionnaire - Disability |
41.7; 10.6; 10.2; 8.5 | — |
| SECONDARY Hand Function: DASH Questionnaire - Work |
46.1; 11.1; 7.8; 5.8 | — |
| SECONDARY Hand Function: DASH Questionnaire - Sport |
48.7; 6.7; 10.1; 2.2 | — |
Summary
This study is designed to document the objective and subjective measurements after trapeziometacarpal athroplasty with ARPE prosthesis and to compare those to literature values of outcome after trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition (LRTI), as published in a recent meta-analysis.
Eligibility Criteria
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the package insert of the implant.
Inclusion Criteria
- patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
- patients willing to return for follow up evaluation.
Exclusion Criteria
- local or systemic infections
- severe muscular, neurological or vascular deficiencies of the extremity involved
- bone destruction or poor bone to affect implant stability
- allergy to any of the components of the implant
Data sourced from ClinicalTrials.gov (NCT01904019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.