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Completed

NCT Number: NCT03196193

CM Asia Nail With AS2 Without AS2 （AS2 Study）

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.

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Key information

Conditions

Trochanteric Fracture of Femur

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kure Kyosai Hospital, Kure, Hiroshima, Japan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open Reduction and Internal Fixation

Procedure

Fractured bone fragments are reduced and stabilized by intramedullary nail.

ZNN CM Asia

Device

Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.

Anterior Support Screw

Device

Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.

Other names: ACE 4.5/5.0mm cannulated lag-screw

Primary outcomes

  1. Number of Patient With and Without Excessive Lag Screw Sliding Distance

    Time frame: Postoperative 2-3 week

    Number of patient was counted based on CT measurement results. Relative position of lag screw between CT images taken at both immediate and 2-3 weeks postoperatively was measured and recorded in value (e.g., 1.5 mm). This was called as "lag screw sliding distance". Four millimeter was set as threshold to define success and failure. Less than 4mm of lag screw sliding distance was recognized as Success and equal to or more than 4mm of lag screw sliding distance was recognized as Failure.

Secondary outcomes

  1. Surgery Time

    Time frame: Intraoperative, an average of 1 hour

    Surgery time from skin incision to closure

  2. Image Assessment Using Computed Tomography (CT)

    Time frame: 2-3 weeks postoperatively

    Number of patient was counted based on CT measurement results. When the fracture reduction position achieved at surgery was maintained at 2 to 3 weeks, then the patient was categorized as success (Reduction position maintained). On the other hand, patient was categorized as failure (Reduction position changed) in the case that the fracture reduction position was changed.

    Fracture repair position was categorized into three; "Anterior", "Neutral" or "Posterior" based on relative position of proximal bone fragment and distal bone fragment.

    This analysis only includes patients whose fracture reduction position at immediate postoperative CT was either "Anterior" or "Neutral".

    If both immediate and 2-3 weeks postoperative CT images show same fracture reduction position (example: "Anterior" at immediate postoperatively & "Anterior" at 2-3 weeks postoperatively), then the patient was recognized as Success (Reduction position maintained).

  3. Intraoperative Safety

    Time frame: Intraoperative

    This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2017
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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