Outcome Comparison Between PFNA and InterTAN

Intertrochanteric Fracture Clinical Trial

Official title:

Outcome Comparison Between PFNA and InterTAN in Intertrochanteric Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01797237
• Other study ID #: PLAGH OD 14
• Status: Recruiting
• Phase: Phase 4
• First received: February 20, 2013
• Last updated: February 4, 2015
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: February 2015
• Source: Chinese PLA General Hospital
• Contact: Peifu Tang, MD
• Phone: 861099638101
• Email: pftang301[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Fractures
• Intertrochanteric Fracture

Intervention

Device:
• PFNA

• InterTAN

Locations

Country	Name	City	State
China	The General Hospital of the People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peifu Tang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Death, implant breakage/failure, secondary fracture, infection and VTE (Venous Thromboembolism).	Six months	Yes
Primary	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	Yes
Secondary	Bone healing condition	Bone healing condition was checked by radiological examination.	Six months	Yes