CapFlex-PIP© Motion

Arthroplasty Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425319
• Other study ID #: CapMotion
• Status: Completed
• 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
• 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-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

Related Conditions & MeSH terms

• Arthroplasty
• Finger Joint
• Motion
• Replacement

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