Results of the Tactys Implant in Proximal Interphalangeal Joint Arthroplasty

Interphalangeal; Osteoarthritis, Proximal (Bouchard) Clinical Trial

Official title:

Proximal Interphalangeal Joint Arthroplasty With the TACTYS® Prosthesis : Clinical and Radiographic Results at Medium Term.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658459
• Other study ID #: 2020PI110
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: July 2021

Study information

• Verified date: November 2020
• Source: Central Hospital, Nancy, France
• Contact: Aude LOZANO, resident
• Phone: 0611434813
• Email: a.lozano[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interphalangeal; Osteoarthritis, Proximal (Bouchard)
• Osteoarthritis

Intervention

Procedure:
• Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire	Nancy	Meurthe ET Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	range of motion in degrees	measurement of range of motion in degrees	minimal one year post-operative
Primary	force in kilograms	measurement of force with jamar and pinch tests in kilograms	minimal one year post-operative
Primary	pain with the digital pain scale	measurement of pain with the digital pain scale to zero to ten	minimal one year post-operative
Primary	functional score with the Quick DASH	measurement of the quick-DASH functional score to zeo to hundred	minimal one year post-operative
Secondary	register the complication and their apparition in time		minimal one year post-operative
Secondary	assess satisfaction	assess the patient's satisfaction : very satisfied, satisfied, moderate, not satisfied	minimal one year post-operative