THP Hip Fracture Plating System Study

NCT ID: NCT03870477

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2021-03-10

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.

Conditions

Femur 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

Study Design

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

Study Groups

THP Hip Fracture Plating System

THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures

Group Type: OTHER

THP Hip Fracture Plating System with telescoping lag screws

Intervention Type: DEVICE

The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.

Interventions

THP Hip Fracture Plating System with telescoping lag screws

The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 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

Eskenazi Health

Indianapolis, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CSU2017-22T

Identifier Type: -

Identifier Source: org_study_id