Skip to main content
OpenTrials
Completed

NCT Number: NCT02425319

CapFlex-PIP© Motion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Finger Joint Arthroplasty Motion Replacement

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schulthess Klinik

Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Active PIP joint range of motion (flexion and extension lag) during motion analysis

    Time frame: 1-5 years postoperative

  2. Lateral stability in coronal plane (to ulnar and radial side) during motion analysis

    Time frame: 1-5 years postoperative

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 23, 2015
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.