Menu
Recruiting NCT06885359

CoCrMo LOCK Bipolar Femoral Heads FU

— Observational Femoral Fractures Hip Arthropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Femoral Fractures, Hip Arthropathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Post-market Study Evaluating Clinical and Safety Outcomes of Bipolar Hemiarthroplasty Using CoCrMo LOCK Bipolar Femoral Heads in Subjects With Hip Fracture

Overview

Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of CoCrMo LOCK bipolar femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.

Detailed description

The study is aiming to demoranstrate safety and performance of LOCK Bipolar femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).

Primary outcome measures

  • Evaluation of the revision rate of CoCrMo LOCK Bipolar femoral heads at 24 months after surgery. [Time frame: At 24 months after intraoperative visit]
Secondary outcome measures (8)
  • Evaluation of the dislocation rate (including close reduction) in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after bipolar hemiarthroplasty [Time frame: At 24 months after intraoperative visit]
  • Evaluation of the revision incidence of any hip component for any reason at 24 months after bipolar hemiarthroplasty. [Time frame: At 24 months after intraoperative visit]
  • Evaluation of acetabular erosion (according to Baker classification) in subjects with CoCrMo LOCK Bipolar femoral heads at 12 months after Bipolar Hemiarthroplasty. [Time frame: At 12 months after intraoperative visit]
  • Assessment of Harris Hip Score (HHS) at 24 months after Bipolar Hemiarthroplasty with CoCrMo LOCK Bipolar femoral heads. [Time frame: At 24 months after intraoperative visit]
  • Assessment of Oxford Hip Score (OHS) completed by subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty. [Time frame: At 24 months after intraoperative visit]
  • Assessment of Pain Likert-scale in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty. [Time frame: At 24 months after intraoperative visit]
  • Comparison between pre-operative and 4-month walking ability. [Time frame: Performed at preoperative visit and 4months follow up visit]
  • Comparison between pre-operative and 4-month residential status. [Time frame: Performed at preoperative visit and 4months follow up visit]

Eligibility criteria

Inclusion criteria

  • Displaced intracapsular hip fracture (Garden III-IV).
  • Subjects underwent a Bipolar Hemiarthroplasty with a CoCrMo LOCK Bipolar femoral head as per their Indication For Use from January 1st, 2023, onwards.
  • No concurrent joint disease at the time of the surgery.
  • Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.
  • Ability to ambulate independently with or without walking aids before surgery.
  • Subject willingness to participate.

Exclusion criteria

  • Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).
  • Any CoCrMo LOCK Bipolar femoral head contraindication for use as reported in the current Instruction For Use.
  • Pathological fracture secondary to malignant disease.
  • Subjects with rheumatoid arthritis or symptomatic osteoarthritis.
  • Previous treatment to the same hip for a fracture at the time of the surgery.
  • Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.
  • Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.
  • Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Slovenia · 1 center
  • Splošna bolnišnica Celje — Celje

Identifiers

NCT: NCT06885359 · H-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗