Clinical trial NCT03870477: THP Hip Fracture Plating System Study
Official title: Intracapsular and Intertrochanteric Fracture Fixation With the THP Hip Fracture Plating System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With a Revision
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants With Radiographic Fracture Healing of the Femur (RUSH)
timeFrame: 6 weeks
measure: Average FIX-IT Score (Clinical Fracture Healing of the Femur)
timeFrame: 6 weeks
measure: Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)
timeFrame: 6 weeks
measure: Average VAS Pain Score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Ryan Boylan, MBA
role: STUDY_DIRECTOR
References: