Results of the Tactys Implant in Proximal Interphalangeal Joint Arthroplasty

• Conditions: Interphalangeal; Osteoarthritis, Proximal (Bouchard)
• Interventions: Procedure: Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis

• Registration Number: NCT04658459
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time.

Detailed Description

The inclusion criteria is any patient who has undergone a proximal interphalangeal joint arthroplasty with the Tactys prothesis between january 2015 to january 2020 in the Centre Chirurgical Emile Gallé in Nancy.

The functional results evaluated are range of motion, force, pain, functional score as Quick DASH and the radiological one are clinodactyly, periprosthetic ossifications and loosening, dislocation and implant subsidence.

Data is registered from the medical folder of every patient.

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-07
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08
• Primary Completion: 2021-03
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• one or more proximal interphalangeal joint arthroplasty of long fingers with the Tactys prosthesis
• between january 2015 to january 2020
• major
• centre chirurgical emile gallé, centre hospitalier régional universitaire de Nancy

Exclusion Criteria

• minor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Results at short term follow up	Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis	Functional and Radiological results at short-term follow up (one year at least)
Results at middle term follow up	Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis	Functional and Radiological results at the last follow up of the patient (2 years at least)

Primary Outcome Measures

Name	Time	Method
force in kilograms	minimal one year post-operative	measurement of force with jamar and pinch tests in kilograms
range of motion in degrees	minimal one year post-operative	measurement of range of motion in degrees
pain with the digital pain scale	minimal one year post-operative	measurement of pain with the digital pain scale to zero to ten
functional score with the Quick DASH	minimal one year post-operative	measurement of the quick-DASH functional score to zeo to hundred

Secondary Outcome Measures

Name	Time	Method
assess satisfaction	minimal one year post-operative	assess the patient's satisfaction : very satisfied, satisfied, moderate, not satisfied
register the complication and their apparition in time	minimal one year post-operative

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire; 🇫🇷 Nancy, Meurthe ET Moselle, France