Outcome Comparison Between PFNA and InterTAN

Outcome Comparison Between PFNA and InterTAN in Intertrochanteric Fractures

The purpose of this study is to determine whether this two intramedullary fixations are effectively in the treatment of intertrochanteric fracture.

Study Overview

• Status: Unknown
• Conditions: Intertrochanteric Fracture
• Intervention / Treatment: Device: PFNA; Device: InterTAN

Detailed Description

With the progress of aging society, elderly patients with intertrochanteric fractures were occurred more and more. The best recommend treatment is surgical treatment of intramedullary fixation. However, existing methods of intramedullary fixation could not be restored the integrated interior support, and it will occur early hip varus. Meanwhile, the varus deformity will no longer develop if the two ends contact with wach other. This new intramedullary fixation device can overcome the existing shortage of intramedullary fixation devices and supporting the inside of the problem. It can prompting the fracture site to obtain a stronger initial stability, improve fracture healing rate, reduce the incidence of varus and allow patients with early weight-bearing walking.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • The General Hospital of the People's Liberation Army
      • Contact: Peifu Tang, MD; Phone Number: 861099638101; Email: pftang301@126.com
      • Principal Investigator: Lihai Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult men or women aged 18 years and older (with no upper age limit).
• Fracture of the intertrochanteric fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
• Operative treatment of fractures within 14 days of presenting to the emergency room.
• Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
• Anticipated medical optimalization for operative fixation of the hip.
• Provision of informed consent by patient or legal guardian.
• No other major trauma.

Exclusion Criteria:

• Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
• Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
• Retained hardware around the affected hip.
• Infection around the hip (i.e., soft tissue or bone).
• Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
• Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
• Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stable intertrochanteric fracture; The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification.	Device: PFNA; Other Names: Proximal Femoral Nail Antirotation (Synthes); Device: InterTAN; Other Names: InterTAN Femoral Nail (Smith&Nephew)
Experimental: Unstable intertrochanteric fracture; The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification.	Device: PFNA; Other Names: Proximal Femoral Nail Antirotation (Synthes); Device: InterTAN; Other Names: InterTAN Femoral Nail (Smith&Nephew)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Assessment the quality of life by SF-36 (The Short Form Health Survey), ADL (Activities of Daily Living), FIM (Functional Independence Measure).	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone healing condition	Bone healing condition was checked by radiological examination.	Six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Death, implant breakage/failure, secondary fracture, infection and VTE (Venous Thromboembolism).	Six months

Collaborators and Investigators

• Sponsor: Peifu Tang
• Investigators: Study Chair: Peifu Tang, MD, Chinese PLA General Hospital; Study Director: Lihai Zhang, MD, Chinese PLA General Hospital; Principal Investigator: Qi Yao, MD, Beijing Shijitan Hospital, Capital Medical University; Principal Investigator: Wen Zhao, MD, Beijing Aerospace General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Estimate): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: surgery; intramedullary nail; fixation
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: PLAGH OD 14