N-Force Screws Augmented With N-Force Blue in Hip Fractures

NCT ID: NCT03807349

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-21
• Study Completion Date: 2021-03-11

Brief Summary

The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.

Detailed Description

Primary Endpoint:

• Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.

Secondary Endpoints:

• Radiographic and clinical fracture healing of the proximal femur using standard scoring methods and patient satisfaction.
• Cost effectiveness

Conditions

Intracapsular Proximal Femur Fracture; Garden Grade I Subcapital Fracture of Femoral Neck; Garden Grade II Subcapital Fracture of Femoral Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

N-Force Screws

N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.

Group Type: OTHER

N-Force Screws Augmented with N-Force Blue

Intervention Type: DEVICE

N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)

Interventions

N-Force Screws Augmented with N-Force Blue

N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient has primary Garden I or II intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with N-Force Blue.
• Patient receives operative treatment within 7 days of injury.
• Patient was ambulatory before injury.
• Patient is 50 years of age or older.

Exclusion Criteria

• Patient has Garden III or IV intracapsular proximal femur fracture.
• Patient has major cognitive impairment (including dementia).
• Patient is on dialysis.
• Patient is not expected to survive follow-up schedule.
• Patient is expected to have problems maintaining follow-up compliance, i.e. patients with no fixed address, patients not mentally competent to give informed consent, etc. (Investigator's discretion).
• Patient is a prisoner.
• Patient is known to be pregnant and/or breastfeeding.
• Patient is a known alcohol or drug abuser.
• Patient had previous/has active acute or chronic infections, especially at the site of operation.
• Patient has non-viable bone, or has areas where surrounding bone is not viable or capable of supporting and anchoring the implant.
• Patient has traumatic injuries with open wounds or close to the proximal femur fracture, which are likely to become infected.
• Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
• Physical conditions, in the opinion of the investigator, that would prohibit adequate implant support or impede healing.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Boylan, MBA

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Stanford University

Stanford, California, United States

Washington University

St Louis, Missouri, United States

Donald B Slocum Research and Education Foundation

Eugene, Oregon, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CMU2017-60T

Identifier Type: -

Identifier Source: org_study_id