CM Asia Nail With AS2 Without AS2 （AS2 Study）

NCT03196193 | Completed Results FDA Device

• 1 other identifier: T.CR.I.AP.16.4
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 12

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.

Conditions

Trochanteric Fracture of Femur

Outcome Measures

Primary Outcomes (1)

• Number of Patient With and Without Excessive Lag Screw Sliding Distance

  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.

  Postoperative 2-3 week

Secondary Outcomes (3)

• Surgery Time

  Intraoperative, an average of 1 hour

• Image Assessment Using Computed Tomography (CT)

  2-3 weeks postoperatively

• Intraoperative Safety

  Intraoperative

Study Arms (2)

ZNN CM Asia with AS2 technique

EXPERIMENTAL

Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail. Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw).

Procedure: Open Reduction and Internal Fixation; Device: ZNN CM Asia; Device: Anterior Support Screw

ZNN CM Asia without AS2 technique

ACTIVE COMPARATOR

Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.

Procedure: Open Reduction and Internal Fixation; Device: ZNN CM Asia

Interventions

Open Reduction and Internal Fixation PROCEDURE

Fractured bone fragments are reduced and stabilized by intramedullary nail.

ZNN CM Asia with AS2 technique; ZNN CM Asia without AS2 technique

ZNN CM Asia DEVICE

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

ZNN CM Asia with AS2 technique; ZNN CM Asia without AS2 technique

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.

Also known as: ACE 4.5/5.0mm cannulated lag-screw

ZNN CM Asia with AS2 technique

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (12)

Kure Kyosai Hospital

Kure, Hiroshima, 737-8505, Japan

Location

Toyooka Hospital

Toyooka, Hyōgo, 668-8501, Japan

Location

Kasugai Municipal Hospital

Aichi, Kasugai, 486-8510, Japan

Location

Hoshigaoka Medical Center

Hirakata, Osaka, 573-8511, Japan

Location

Numazu City Hospital

Numazu, Shizuoka, 410-0302, Japan

Location

Saiseikai Takaoka Hospital

Takaoka, Toyama, 933-8525, Japan

Location

Kyushu Central Hospital

Fukuoka, 815-8588, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, 861-4193, Japan

Location

Niigata Central Hospital

Niigata, 950-8556, Japan

Location

Okayama Red Cross Hospital

Okayama, 700-8607, Japan

Location

Okayama Rosai Hospital

Okayama, 702-8055, Japan

Location

Saga Pref. Medical Centre Koseikan

Saga, 840-8571, Japan

Location

MeSH Terms

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Senior Manager of Clinical Affairs
• Organization: Zimmer Biomet G.K.

takahito.nakai@zimmerbiomet.com

+81-3-6402-6610

Study Officials

• Takashi Maehara, MD, Ph. D

  Kagawa Rosai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: (Investigational group) or ZNN CM Asia without AS2 technique (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using a blocked randomization procedure. The block size will not be disclosed to the sites, and the doctor or other health care professional will not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At surgery, intervention group using ZNN CM Asia with AS2 technique. At surgery, conventional group using ZNN CM Asia without AS2 technique.

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: June 22, 2017
• Study Start: March 21, 2017
• Primary Completion: April 2, 2020
• Study Completion: April 9, 2020
• Last Updated: September 29, 2020
• Results First Posted: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (12)