Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

Not yet recruiting

• Conditions: Loosening, Prosthesis; Hip Arthropathy

• Registration Number: NCT06924567
• Lead Sponsor: Georgios Tsikandylakis, MD PhD

Brief Summary

The goal of this validation study is to compare the preoperative implant stability, assessed by Implant Movement Analysis (IMA), provocation dual CT scans, with the intraoperative stability evaluation in revision hip arthoplasty. The main question it aims to answer is:

Does IMA reflect the intraoperative clinical evaluation of implant stability? Participants scheduled for revision hip arthoplasty will undergo IMA preoperativelly in addition to rutine clinical work up. During revision arthoplasty, a surgeon blinded to the IMA results will assess clinically the stability of the hip prosthesis. IMA will be compared with the intraoperative findings to assess IMAs sensitivity and specificity

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-05
• Study First Submitted QC: 2025-04-05
• Last Update Submitted: 2025-04-05
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Study Start: 2025-05
• Primary Completion: 2028-04-30
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cup and stem stability	within 2 months month	The stability of the cup and the stem is evaluated: 1. Preoperatively with IMA as binary outcome (loose/not loose).; 2. Intraoperatively by the surgeon as binary outcome (loose/notloose).

Trial Locations

Locations (4)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Hässleholm Hospital; 🇸🇪 Hässleholm, Sweden

Danderyd Hospital; 🇸🇪 Stockholm, Sweden

Akademiska University Hospital; 🇸🇪 Uppsala, Sweden