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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02425319
Other study ID # CapMotion
Secondary ID
Status Completed
Phase
First received April 20, 2015
Last updated April 25, 2018
Start date November 14, 2017
Est. completion date April 18, 2018

Study information

Verified date April 2018
Source Schulthess Klinik
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 18, 2018
Est. primary completion date April 18, 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIPĀ© 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Schulthess Klinik Zürich

Sponsors (1)

Lead Sponsor Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Active PIP joint range of motion (flexion and extension lag) during motion analysis 1-5 years postoperative
Primary Lateral stability in coronal plane (to ulnar and radial side) during motion analysis 1-5 years postoperative
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