NCT03870477

THP Hip Fracture Plating System Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2019-01-16
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2019-03-12
• Last updated: 2022-05-12
• Results posted: 2022-05-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study