CapFlex-PIP© Motion

April 25, 2018 updated by: Stephan Schindele, Schulthess Klinik

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8008
        • Schulthess Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients with CapFlex-PIP© implant
patients with silicone implant
patients with healthy PIP joints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Active PIP joint range of motion (flexion and extension lag) during motion analysis
Time Frame: 1-5 years postoperative
1-5 years postoperative
Lateral stability in coronal plane (to ulnar and radial side) during motion analysis
Time Frame: 1-5 years postoperative
1-5 years postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schulthess Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Actual)

April 18, 2018

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CapMotion

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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