CoCrMo LOCK Bipolar Femoral Heads FU

NCT06885359 | Not Yet Recruiting

• 1 other identifier: H-46
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Fractures; Hip Arthropathy

Keywords

Femoral head; Partial Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Evaluation of the revision rate of CoCrMo LOCK Bipolar femoral heads at 24 months after surgery.

  At 24 months after intraoperative visit

Secondary Outcomes (8)

• 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.

  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.

  At 24 months after intraoperative visit

Study Arms (1)

CoCrMo LOCK bipolar femoral head implanted patient

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Splošna bolnišnica Celje

Celje, 3000, Slovenia

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Monica Novello

CONTACT

3358162087; monica.novello@enovis.com

Francesca Citossi

CONTACT

+39 0432 945511; clinicalresearch@enovis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

SL (1)