Outcome Comparison Between PFNA and InterTAN

NCT ID: NCT01797237

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-10-31

Brief Summary

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

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.

Conditions

Intertrochanteric Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stable intertrochanteric fracture

The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification.

Group Type: EXPERIMENTAL

PFNA

Intervention Type: DEVICE

InterTAN

Intervention Type: DEVICE

Unstable intertrochanteric fracture

The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification.

Group Type: EXPERIMENTAL

PFNA

Intervention Type: DEVICE

InterTAN

Intervention Type: DEVICE

Interventions

PFNA

Intervention Type: DEVICE

InterTAN

Intervention Type: DEVICE

Other Intervention Names

Proximal Femoral Nail Antirotation (Synthes); InterTAN Femoral Nail (Smith&Nephew)

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peifu Tang

OTHER

Sponsor Role: lead

Responsible Party

Peifu Tang

Chief, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peifu Tang, MD

Role: STUDY_CHAIR

Chinese PLA General Hospital

Lihai Zhang, MD

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Qi Yao, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Shijitan Hospital, Capital Medical University

Wen Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Aerospace General Hospital

Locations

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peifu Tang, MD

Role: CONTACT

pftang301@126.com

861099638101

Lihai Zhang, MD

Role: CONTACT

zhanglihai@gmail.com

861068212342

Facility Contacts

Peifu Tang, MD

Role: primary

pftang301@126.com

861099638101

Other Identifiers

PLAGH OD 14

Identifier Type: -

Identifier Source: org_study_id