Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

N/ANot Yet RecruitingNCT06924567

Georgios Tsikandylakis, MD PhD600 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Loosening, Prosthesis Hip Arthropathy

Interventions

Implant motion provocation CTDIAGNOSTIC_TEST

Implant Movement Analysis. A low dose CT scan is performed with the hip fixed in external rotation. Then another low dose CT scan is performed with the hip fixed in internal rotation.The CT scans are then overimposed to each other and implant motion in relation to host bone is visualized,

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (4)

Sahlgrenska University Hospital

Gothenburg, Sweden

Hässleholm Hospital

Hässleholm, Sweden

Danderyd Hospital

Stockholm, Sweden

Akademiska University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

Cup and stem stability

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).

Time frame: within 2 months month