Back to resultsTHP Hip Fracture Plating System Study (THP)
Primary Purpose
Femur Fracture, Femur Fracture Intertrochanteric, Garden Grade I Subcapital Fracture of Femoral Neck
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
THP Hip Fracture Plating System with telescoping lag screws
Sponsored by
About this trial
This is an interventional treatment trial for Femur Fracture focused on measuring Cannulated Screws, Lag Screws, Compression Screws, Telescoping Lag Screws, Cortical Screws, Hip Fracture Plate
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.
Sites / Locations
- Eskenazi Health
- University of Michigan
- Inova Fairfax Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
THP Hip Fracture Plating System
Arm Description
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
Outcomes
Primary Outcome Measures
Number of Participants With a Revision
Revision rate due to device related complication(s) or non-union of the femur.
Secondary Outcome Measures
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).
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.
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').
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])
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03870477
Brief Title
THP Hip Fracture Plating System Study
Acronym
THP
Official Title
Intracapsular and Intertrochanteric Fracture Fixation With the THP Hip Fracture Plating System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Business decision to remove product from portfolio.
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Cannulated Screws, Lag Screws, Compression Screws, Telescoping Lag Screws, Cortical Screws, Hip Fracture Plate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
THP Hip Fracture Plating System
Arm Type
Other
Arm Description
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
Intervention Type
Device
Intervention Name(s)
THP Hip Fracture Plating System with telescoping lag screws
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With a Revision
Description
Revision rate due to device related complication(s) or non-union of the femur.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Radiographic Fracture Healing of the Femur (RUSH)
Description
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).
Time Frame
6 weeks
Title
Average FIX-IT Score (Clinical Fracture Healing of the Femur)
Description
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.
Time Frame
6 weeks
Title
Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)
Description
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').
Time Frame
6 weeks
Title
Average VAS Pain Score
Description
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])
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Boylan, MBA
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Eskenazi Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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THP Hip Fracture Plating System Study
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