NCT03745976

Questionnaire and Radiography for Prosthesis Follow-up

Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 656 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ever-evolving prosthetic activity as described in a Swedish study that predicts 469 TKA per 10,000 inhabitants in 2130. Increased consultation of controls and post-arthroplasty follow-up is expected. There is a legal obligation to ensure long-term follow-up without official recommendation on follow-up procedures. The objective is to compare a consultation + Xray by the surgeon versus an Xray and a questionnaire completed by the patient who had a knee or hip replacement. This is to demonstrate the equivalence of both. All patients who come back for an annual check of a prosthesis should complete this questionnaire and perform an X-ray of their prosthesis. The study lasts one year and includes all the patients with a previous knee or hip arthroplasty. The result of the questionnaire and Xray will be compared to that of the consultation and Xray.

Detailed description

An english study published an article showing that a follow up by questionnaire versus a consultation was also effective. For this study, investigator is going to take back all the patients having to return to consultation in 2017. . Normally at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively. Thus investigator will be able to see the number of patients seen in consultation compared to the theoretical number The purpose of this study is to highlight the non-inferiority of the questionnaire compared to the consultation for screening for complications at 10 years. If this proves to be the case, only complicating patients could be reviewed by calling them to the radio and their questionnaire.

Conditions

• Hip and Knee Arthroplasties
• Without Known Complication
• Annual Follow-up

Interventions

Type	Name	Description
PROCEDURE	questionnaire and Xray for all patients	questionnaire and Xray for all patients

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-10-30
• Completion: 2019-10-30
• First posted: 2018-11-19
• Last updated: 2020-04-07

Locations

1 site across 1 country: France