Outcome Comparison Between PFNA and InterTAN

Phase 4

• Conditions: Intertrochanteric Fracture
• Interventions: Device: PFNA; Device: InterTAN

• Registration Number: NCT01797237
• Lead Sponsor: Peifu Tang

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-06
• Primary Completion: 2015-09
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unstable intertrochanteric fracture	InterTAN	The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification.
Unstable intertrochanteric fracture	PFNA	The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification.
Stable intertrochanteric fracture	PFNA	The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification.
Stable intertrochanteric fracture	InterTAN	The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Bone healing condition	Six months	Bone healing condition was checked by radiological examination.

Trial Locations

Locations (1)

The General Hospital of the People's Liberation Army; 🇨🇳 Beijing, Beijing, China