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Search / Trial NCT06924567

Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

Launched by GEORGIOS TSIKANDYLAKIS, MD PHD · Apr 5, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Implant Stabilty Tha Radiographic Evaluation Ima Implant Movement Analysis Revision Tha

ClinConnect Summary

This clinical trial is studying how well a special test called Implant Movement Analysis (IMA) can predict the stability of hip implants before patients undergo revision surgery. The main goal is to see if the IMA results match what surgeons observe during the actual surgery. Participants in this study will be individuals scheduled for revision hip surgery due to issues like loosening of the implant. Before their surgery, they will have the IMA test done, along with routine checks by their doctor. During the surgery, a surgeon who doesn’t know the IMA results will evaluate how stable the implant is, and researchers will compare these findings.

To be eligible for this trial, patients need to be among the 600 scheduled for revision surgery due to loosening of the hip implant, but without clear signs of looseness on recent X-rays. It's important that these X-rays are less than eight weeks old before the surgery. People who have already been evaluated as having loose implants or who have had repeated dislocations of their hip implant won’t be included in the study. Overall, participants will help researchers understand if the IMA test can be a reliable tool in assessing hip implant stability, which could improve future surgeries.

Gender

ALL

Eligibility criteria

  • Inclusion criteria: 600 consecutive patients scheduled for revision THA due to aseptic loosening, in whom, one component has no convincing loosening signs, based on the preoperative plain radiographs and clinical assessment by the attending surgeon. The radiographs should be not older than 8 weeks prior to surgery.
  • Exclusion criteria:
  • Both cup and stem have been preoperatively evaluated as loose by the attending surgeon, based on the preoperative plain radiographs.
  • Instability with repeating dislocation of the THA Non-aseptic revision surgery, based on preoperative work up. Participants are excluded after inclusion if revision surgery is cancelled.

About Georgios Tsikandylakis, Md Phd

Dr. Georgios Tsikandylakis, MD, PhD, is a distinguished clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a robust background in clinical medicine and a doctoral focus on innovative therapeutic strategies, Dr. Tsikandylakis leads initiatives that bridge the gap between scientific discovery and clinical application. His expertise encompasses a range of therapeutic areas, emphasizing rigorous study design, ethical standards, and meticulous oversight to ensure the integrity and success of clinical trials. Through collaborative partnerships and a patient-centered approach, Dr. Tsikandylakis aims to drive meaningful advancements in healthcare.

Locations

Gothenburg, , Sweden

Stockholm, , Sweden

Hässleholm, , Sweden

Uppsala, , Sweden

Patients applied

0 patients applied

Trial Officials

Henrik Malchau, MD, PhD

Study Chair

Sahlgrenska University Hospital

Georgios Tsikandylakis

Principal Investigator

Sahlgrenska University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported