Radiographic Stability of Hip Prosthesis Prior to Revision Surgery (MULTICIMA)

Georgios Tsikandylakis, MD PhD

Status

Not yet enrolling

Conditions

Hip Arthropathy

Loosening, Prosthesis

Treatments

Diagnostic Test: Implant motion provocation CT

Study type

Observational

Funder types

Other

Identifiers

NCT06924567

284803

Details and patient eligibility

About

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

Enrollment

600 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.