Clinical trial NCT03196193: CM Asia Nail With AS2 Without AS2 （AS2 Study）
Official title: Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trochanteric Fracture of Femur
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-06-22
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At surgery, intervention group using ZNN CM Asia with AS2 technique. At surgery, conventional group using ZNN CM Asia without AS2 technique.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare reduction positon maintenance rate at 3 weeks post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2 technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum 15sites, total study duration is 22months.

Detailed description: Objective： To compare fracture reduction maintenance rate at 2-3weeks post-operatively between patients operated with AS2 (investigational group) and patients operated without AS2 (Control group) using same implant system (ZNN CM Asia, Zimmer Biomet).

Endpoint： Primary： The rate of reduction position maintenance at 2-3 weeks post-operatively. Secondary： Surgery time / fracture type / postoperative reduction position / CT assessment / Safety information

Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria.

* Eligible for intramedullary nailing.
* Fracture type is classified as 3-partB or 4-part fracture in 3D-CT (Three Dimensional Computed Tomography) classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT (Computed Tomography) assessment.(In the case of classified in radiograph (X-ray) at preoperative: Classified as Type 4 or Type 5 in Jensen classification, and combination of subtype P in lateral classification (Ikuta))
* Japanese Male or female
* \> 20 years of age
* Primary closed intertrochanteric fracture of the femur
* Subjects willing to return for follow-up evaluations.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study.

* Patient who cannot take CT image within 3 days and 2-3weeks after surgery.
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions.

Primary outcomes:
measure: Number of Patient With and Without Excessive Lag Screw Sliding Distance
timeFrame: Postoperative 2-3 week
Secondary outcomes:
measure: Surgery Time
timeFrame: Intraoperative, an average of 1 hour
measure: Image Assessment Using Computed Tomography (CT)
timeFrame: 2-3 weeks postoperatively
measure: Intraoperative Safety
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Kure
country: Japan
facility: Kure Kyosai Hospital
state: Hiroshima
city: Toyooka
country: Japan
facility: Toyooka Hospital
state: Hyogo
city: Aichi
country: Japan
facility: Kasugai Municipal Hospital
state: Kasugai
city: Hirakata
country: Japan
facility: Hoshigaoka Medical Center
state: Osaka
city: Numazu
country: Japan
facility: Numazu City Hospital
state: Shizuoka
city: Takaoka
country: Japan
facility: Saiseikai Takaoka Hospital
state: Toyama
city: Fukuoka
country: Japan
facility: Kyushu Central Hospital
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Niigata
country: Japan
facility: Niigata Central Hospital
city: Okayama
country: Japan
facility: Okayama Red Cross Hospital
city: Okayama
country: Japan
facility: Okayama Rosai Hospital
city: Saga
country: Japan
facility: Saga Pref. Medical Centre Koseikan
Study officials:
affiliation: Kagawa Rosai Hospital
name: Takashi Maehara, MD, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: