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CapFlex-PIP© Motion

Motion Analysis of the Proximal Interphalangeal Joint in Healthy Hands, as Well as in Osteoarthritis Hands Following Implantation With the New CapFlex-PIP© Implant Compared With Silicone Implants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02425319
Enrollment
30
Registered
2015-04-23
Start date
2017-11-14
Completion date
2018-04-18
Last updated
2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Finger Joint, Motion, Replacement

Brief summary

The purpose of this study is to describe and to compare the motion analysis parameters, i.e. motion and stability of proximal interphalangeal joints, which were treated with a CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion analysis of untreated healthy hands.

Interventions

None listed

Sponsors

Schulthess Klinik
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or * Patient with one untreated healthy hand without joint osteoarthritis * Patient aged 50 years and over * Patient willing and able to give written informed consent to participate in the study

Exclusion criteria

* Inflammatory disease (e.g. rheumatoid arthritis) * Pregnant women * German language barrier to complete the questionnaires * Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) * Legal incompetence * Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

Design outcomes

Primary

MeasureTime frame
Active PIP joint range of motion (flexion and extension lag) during motion analysis1-5 years postoperative
Lateral stability in coronal plane (to ulnar and radial side) during motion analysis1-5 years postoperative

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026