Intracapsular and Intertrochanteric Fracture Fixation With the THP Hip Fracture Plating System

Zimmer Biomet3 sites in 1 country1 target enrollmentJanuary 16, 2019

ConditionsFemur Fracture Femur Fracture Intertrochanteric Garden Grade I Subcapital Fracture of Femoral Neck Garden Grade II Subcapital Fracture of Femoral Neck Garden Grade III Subcapital Fracture of Femoral Neck Garden Grade IV Subcapital Fracture of Femoral Neck

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Femur Fracture
Sponsor: Zimmer Biomet
Enrollment: 1
Locations: 3
Primary Endpoint: Number of Participants With a Revision
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.

Detailed Description

Primary Endpoint: • Revision rate due to device related complication(s) or non-union of the femur. Secondary Endpoints: • Radiographic and clinical fracture healing of the proximal femur using standard scoring methods.

Registry

clinicaltrials.gov

Start Date

January 16, 2019

End Date

March 10, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient must be 18 years of age or older.
•Patient must be eligible for an open reduction and internal fixation of the proximal femur.
•Patient must have an intracapsular or intertrochanteric fracture.
•Patient must have need for alignment, stabilization, and reduction of bone fractures.
•Patient must have ability and willingness to follow postoperative care instructions until healing is complete.
•Patient must be in good nutritional state.
•Patient must be able and willing to sign the IRB/EC approved informed consent.

Exclusion Criteria

•Patient is a prisoner.
•Patient is a current alcohol or drug abuser.
•Patient is known to be pregnant or breastfeeding.
•Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent.
•Infection.
•Patient conditions including bloody supply limitations, obesity or insufficient quantity or quality of bone.
•Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
•Patient has foreign body sensitivity. Where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
•Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.

Outcomes

Primary Outcomes

Number of Participants With a Revision

Time Frame: 6 weeks

Revision rate due to device related complication(s) or non-union of the femur.

Secondary Outcomes

Number of Participants With Radiographic Fracture Healing of the Femur (RUSH)(6 weeks)
Average FIX-IT Score (Clinical Fracture Healing of the Femur)(6 weeks)
Average VAS Pain Score(6 weeks)
Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)(6 weeks)