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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
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Revision Rate [ Time Frame: 12 months ]
    Revision rate due to device related complication(s) or non-union of the femur.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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])



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, Indiana
Eskenazi Health
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
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold, RN, MBA Zimmer Biomet
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03870477    
Other Study ID Numbers: CSU2017-22T
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Zimmer Biomet:
Cannulated Screws
Lag Screws
Compression Screws
Telescoping Lag Screws
Cortical Screws
Hip Fracture Plate
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Hip Injuries
Leg Injuries