THP Hip Fracture Plating System Study (THP)

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

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.

Study Overview

• Status: Terminated
• Conditions: Femur Fracture; Garden Grade I Subcapital Fracture of Femoral Neck; Garden Grade II Subcapital Fracture of Femoral Neck; Femur Fracture Intertrochanteric; Garden Grade III Subcapital Fracture of Femoral Neck; Garden Grade IV Subcapital Fracture of Femoral Neck
• Intervention / Treatment: Device: THP Hip Fracture Plating System with telescoping lag screws

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: THP Hip Fracture Plating System; THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Revision	Revision rate due to device related complication(s) or non-union of the femur.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Radiographic Fracture Healing of the Femur (RUSH)	Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing).	6 weeks
Average FIX-IT Score (Clinical Fracture Healing of the Femur)	The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.	6 weeks
Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)	The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').	6 weeks
Average VAS Pain Score	VAS pain scale is a unidimensional measure of pain intensity. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])	6 weeks

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2019
• Primary Completion (ACTUAL): March 10, 2021
• Study Completion (ACTUAL): March 10, 2021

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (ACTUAL): March 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cannulated Screws; Lag Screws; Compression Screws; Telescoping Lag Screws; Cortical Screws; Hip Fracture Plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: CSU2017-22T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes