Clinical trial NCT01797237: Outcome Comparison Between PFNA and InterTAN
Official title: Outcome Comparison Between PFNA and InterTAN in Intertrochanteric Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intertrochanteric Fracture
Keywords: surgery
fixation
intramedullary nail
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Quality of life
timeFrame: six months
Secondary outcomes:
measure: Bone healing condition
timeFrame: Six months
Other outcomes:
measure: Complications
timeFrame: Six months
Locations:
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Peifu Tang, MD
role: STUDY_CHAIR
affiliation: Chinese PLA General Hospital
name: Lihai Zhang, MD
role: STUDY_DIRECTOR
affiliation: Beijing Shijitan Hospital, Capital Medical University
name: Qi Yao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Aerospace General Hospital
name: Wen Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: