CoCrMo LOCK Bipolar Femoral Heads FU

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Fractures; Hip Arthropathy

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).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Monica Novello; Phone Number: 3358162087; Email: monica.novello@enovis.com
• Study Contact Backup: Name: Francesca Citossi; Phone Number: +39 0432 945511; Email: clinicalresearch@enovis.com

Study Locations

• Slovenia
  • Celje, Slovenia, 3000
    • Splosna bolnisnica Celje
    • Contact: Dario Kalacun; Phone Number: +386 70 34 34 36; Email: Dario.kalacun@sb-celje.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who underwent partial hip arthroplasty with CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CoCrMo LOCK bipolar femoral head implanted patient; Patients who underwent hip arthroplasty with CoCrMo LOCK bipolar femoral heads from 1at January 2023 onwards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the revision rate of CoCrMo LOCK Bipolar femoral heads at 24 months after surgery.	At 24 months after intraoperative visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the dislocation rate (including close reduction) in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after bipolar hemiarthroplasty		At 24 months after intraoperative visit
Evaluation of the revision incidence of any hip component for any reason at 24 months after bipolar hemiarthroplasty.		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.		At 12 months after intraoperative visit
Assessment of Harris Hip Score (HHS) at 24 months after Bipolar Hemiarthroplasty with CoCrMo LOCK Bipolar femoral heads.	The Harris Hip Score goes from 0 to 100, which is the best result.	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.	The Oxford Hip Score goes from 0 to 48, with 48 being the best outcome	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.	The pain Likert-scale is a 6-point scale: - severe and spontaneous - severe when walking - tollerable - occurs after activity - light intermittent - no pain	At 24 months after intraoperative visit
Comparison between pre-operative and 4-month walking ability.	Functional evaluation At the pre-operative time-point, the ability to walk is categorized in: "able to walk without aids",; "able to walk using one walking aid",; "able to walk using two walking aids",; "able to walk using the walking frame"; "unable to walk" (wheelchair or bed-ridden subjects) At the 4-month post-operative time-point, the ability to walk is investigated is categorized in: "maintained" (if the subject is able to walk independently as before, with aids if necessary); "not maintained" (if the subject needs support from another person or uses a wheelchair or is bed-ridden)	Performed at preoperative visit and 4months follow up visit
Comparison between pre-operative and 4-month residential status.	Daily habit At pre-operative timepoint, subjects are categorized as subjects that before the fracture were used to live: at their own home (alone or with assistance),; in a sheltered home for independent people,; in a nursing home for people who need assistance with personal care. At 4-month post-operative timepoint, the residential status is categorised in: maintained (if the subject is living in the same dwelling as before fracture),; not maintained (if the subject moved to a sheltered accommodation or a nursing home)	Performed at preoperative visit and 4months follow up visit

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Femoral head; Partial Hip Arthroplasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures
• Other Study ID Numbers: H-46

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No