Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail

The purpose of this study is to determine whether this new intramedullary fixation is effective in the treatment of intertrochanteric fracture.

Study Overview

• Status: Recruiting
• Conditions: Intertrochanteric Fracture
• Intervention / Treatment: Device: new type of intramedullary nail; Device: The intramedullary nail of PFNA

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.

This new type of intramedullary fixation of intertrochanteric fractures of devices, including a proximal femoral anatomy and adapt to proximal femoral nail, proximal femoral nail through the femoral head and distal femur compression screw locking screw, its main features are:

1. The proximal femoral nail was made from titanium, its proximal part is narrow inside and wide outside structure. It looks like a trapezoidal in cross-section. This device was matched with the anatomy of proximal femur and its mechanical reliability.
2. The tip of compression screw was designed thread. It can come through the intramedullary nail, produce slide and sustained pressure.
3. The femoral support screw was made in cylindrical, had a blunt rounded tip. The tip of the femoral support screw was tabling with the groove of compression screw. This design can support interior mechanical stability. At the same time, the support screw from the femoral head and neck compression screw can slide fine-tuning, so it has a direct offset against varus and femoral neck rotating shift to prevent secondary loss of fracture reduction. The screw in the femoral head also can prevent cutting occurs.
4. This device can be used in minimally invasive approach of percutaneous and implanted in body. Reduce reduction time, fracture interference and help the natural healing of fractures.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tang Peifu, Dr.; Phone Number: 861099638101; Email: pftang301@126.com
• Study Contact Backup: Name: Shen Jing, Dr.; Phone Number: 8613718623511; Email: orthjing@yahoo.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Orthopedics department; The General Hospital of the People's Liberation Army
      • Contact: Tang Peifu, Dr.; Phone Number: 861099638101; Email: pftang301@126.com
      • Principal Investigator: Zhang li Hai, Dr.
      • Sub-Investigator: Shen Jing, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Unstable intertrochanteric fracture fixed with novel nail; AO/OTA A2 fracture fixed with novel nail	Device: new type of intramedullary nail; This is a new fixation treat for intertrochanteric fracture.; Other Names: WEIGAO ORTHOPAEDIC DEVICE CO.LTD.; ZL201020121021.6
EXPERIMENTAL: unstable intertrochanteric fracture fixed with PFNA; AO/OTA A2 fracture fixed with PFNA	Device: The intramedullary nail of PFNA; It was used very common in treat with intertrochanteric fracture.; Other Names: AO Foundation; PFNA(proximal femoral nail antirotation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative quality of life score	SF-36 PCS	preoperative, six months and one year postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of fracture healing at three months	fracture healing condition was checked by radiological examination.	three months postoperative
rate of femoral medialization	femoral medialization	one year postoperative
collodiaphyseal angle	collodiaphyseal angle	one year postoperative
weight bearing	time of weight bearing	perioperation
rate of patient satisfaction with treatment	1-year VAS satisfaction	one year postoperative
Hip function score	OHS	preoperative, six months and one year postoperative
time of surgical during	The time from the beginning to the end of the surgery	Perioperative
fluoroscopy time	Duration of fluoroscopy	intraoperative
rate of complications related to implant	cut out, nonunion, implant breakage/failure, infection	one year

Collaborators and Investigators

• Sponsor: Peifu Tang
• Investigators: Study Chair: Tang Peifu, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): September 1, 2022
• Study Completion (ANTICIPATED): August 1, 2024

Study Registration Dates

• First Submitted: September 1, 2011
• First Submitted That Met QC Criteria: September 19, 2011
• First Posted (ESTIMATE): September 20, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 17, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: surgery; intramedullary nail; fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PLAGH OD 12