CapFlex-PIP© Motion

NCT02425319 | Completed

• 1 other identifier: CapMotion
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Finger Joint; Arthroplasty; Replacement; Motion

Outcome Measures

Primary Outcomes (2)

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

  1-5 years postoperative

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

  1-5 years postoperative

Study Arms (3)

patients with CapFlex-PIP© implant

patients with silicone implant

patients with healthy PIP joints

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 23, 2015
• Study Start: November 14, 2017
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

CH (1)