THP Hip Fracture Plating System Study (THP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03870477|
Recruitment Status : Terminated (Business decision to remove product from portfolio.)
First Posted : March 12, 2019
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Device: THP Hip Fracture Plating System with telescoping lag screws||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intracapsular and Intertrochanteric Fracture Fixation With the THP Hip Fracture Plating System|
|Actual Study Start Date :||January 16, 2019|
|Actual Primary Completion Date :||March 10, 2021|
|Actual Study Completion Date :||March 10, 2021|
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.
- Revision Rate [ Time Frame: 12 months ]Revision rate due to device related complication(s) or non-union of the femur.
- Radiographic Fracture Healing of the Femur (RUSH) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]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).
- Clinical Fracture Healing of the Femur (FIX-IT) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]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.
- Clinical Fracture Healing of the Femur (EQ-5D-5L) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]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.
- VAS Pain Scale [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]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])
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870477
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Virginia|
|Inova Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Study Director:||Kacy Arnold, RN, MBA||Zimmer Biomet|