CoCrMo LOCK Bipolar Femoral Heads FU | NCT06885359

Studies
CoCrMo LOCK Bipolar Femoral Heads FU

NCT06885359

Sponsor

Limacorporate S.p.a

Status

Recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Femoral Fractures
Hip Arthropathy

Interventions

Not provided

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 28, 2026Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Mar 11, 2025

First Submission Date that Met QC Criteria

Mar 17, 2025

First Posted Date

Mar 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2026

Last Update Posted Date

Jul 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Label	Type	Description	Intervention Names
CoCrMo LOCK bipolar femoral head implanted patient		Patients who underwent hip arthroplasty with CoCrMo LOCK bipolar femoral heads from 1at January 2023 onwards.

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Monica Novello	Contact	3358162087		monica.novello@enovis.com
Francesca Citossi	Contact	+39 0432 945511		clinicalresearch@enovis.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Splošna bolnišnica Celje	Recruiting	Celje		3000	Slovenia

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries