THP Hip Fracture Plating System Study

Femur Fracture Clinical Trial

— THP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03870477
• Other study ID #: CSU2017-22T
• Status: Terminated
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: March 10, 2021

Study information

• Verified date: April 2022
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Femur Fracture Intertrochanteric
• Fractures, Bone
• 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
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Eskenazi Health	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Revision	Revision rate due to device related complication(s) or non-union of the femur.	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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