N/A
Completed N=240
CM Asia Nail With AS2 Without AS2 （AS2 Study）
Trochanteric Fracture of Femur
Source: ClinicalTrials.gov NCT03196193 ↗
Enrolled (actual)
240
Serious AEs
0.4%
Results posted
Sep 2020
Primary outcomePrimary: Number of Patient With and Without Excessive Lag Screw Sliding Distance — 109; 97; 9; 22 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patient With and Without Excessive Lag Screw Sliding Distance |
109; 97; 9; 22 | — |
| SECONDARY Surgery Time |
68.2; 59.8 | — |
| SECONDARY Image Assessment Using Computed Tomography (CT) |
104; 92; 6; 21 | — |
| SECONDARY Intraoperative Safety |
121; 119; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03196193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.