CapFlex-PIP© Motion

NCT ID: NCT02425319

Last Updated: 2018-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-14

Study Completion Date

2018-04-18

Brief Summary

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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.

Detailed Description

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Conditions

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Finger Joint Arthroplasty Replacement Motion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with CapFlex-PIP© implant

No interventions assigned to this group

patients with silicone implant

No interventions assigned to this group

patients with healthy PIP joints

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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Stephan Schindele

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Schulthess Klinik

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CapMotion

Identifier Type: -

Identifier Source: org_study_id

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