Trochanteric Fracture of Femur
Conditions
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
Interventions
PROCEDUREOpen Reduction and Internal Fixation
Fractured bone fragments are reduced and stabilized by intramedullary nail.
DEVICEZNN CM Asia
Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.
DEVICEAnterior Support Screw
Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
(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.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patient With and Without Excessive Lag Screw Sliding Distance | 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
| Measure | Time frame | Description |
|---|---|---|
| Surgery Time | Intraoperative, an average of 1 hour | Surgery time from skin incision to closure |
| Image Assessment Using Computed Tomography (CT) | 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). |
| Intraoperative Safety | Intraoperative | This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ZNN CM Asia With AS2 Technique 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).
Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.
ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.
Anterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw. | 118 |
| ZNN CM Asia Without AS2 Technique Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.
Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail.
ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. | 119 |
| Total | 237 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Computed Tomography (CT) data missing | 2 | 0 |
Baseline characteristics
| Characteristic | ZNN CM Asia With AS2 Technique | ZNN CM Asia Without AS2 Technique | Total |
|---|---|---|---|
| Age, Continuous | 85.9 years STANDARD_DEVIATION 8.9 | 86.7 years STANDARD_DEVIATION 7.9 | 86.3 years STANDARD_DEVIATION 8.4 |
| Height | 148.9 cm STANDARD_DEVIATION 8.8 | 150.0 cm STANDARD_DEVIATION 9 | 149.4 cm STANDARD_DEVIATION 8.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Japan | 118 participants | 119 participants | 237 participants |
| Sex: Female, Male Female | 103 Participants | 97 Participants | 200 Participants |
| Sex: Female, Male Male | 15 Participants | 22 Participants | 37 Participants |
| Weight | 45.3 kg STANDARD_DEVIATION 9.8 | 46.2 kg STANDARD_DEVIATION 9.3 | 45.8 kg STANDARD_DEVIATION 9.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 119 |
| other Total, other adverse events | 0 / 121 | 0 / 119 |
| serious Total, serious adverse events | 1 / 121 | 0 / 119 |
Outcome results
Primary
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.
Time frame: Postoperative 2-3 week
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ZNN CM Asia With AS2 Technique | Number of Patient With and Without Excessive Lag Screw Sliding Distance | Success (lag screw sliding distance <4mm) | 109 Participants |
| ZNN CM Asia With AS2 Technique | Number of Patient With and Without Excessive Lag Screw Sliding Distance | Failure (lag screw sliding distance >=4mm) | 9 Participants |
| ZNN CM Asia Without AS2 Technique | Number of Patient With and Without Excessive Lag Screw Sliding Distance | Success (lag screw sliding distance <4mm) | 97 Participants |
| ZNN CM Asia Without AS2 Technique | Number of Patient With and Without Excessive Lag Screw Sliding Distance | Failure (lag screw sliding distance >=4mm) | 22 Participants |
Secondary
Image Assessment Using Computed Tomography (CT)
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).
Time frame: 2-3 weeks postoperatively
Population: Participants, whose immediate postoperative reduction position is assessed as either Anterior or Neutral, were eligible.~Eight patients in ZNN CM Asia with AS2 technique group and 6 patients in ZNN CM Asia without AS2 technique group were excluded from this analysis (their immediate postoperative reduction position was Posterior.)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ZNN CM Asia With AS2 Technique | Image Assessment Using Computed Tomography (CT) | Reduction position maintained | 104 Participants |
| ZNN CM Asia With AS2 Technique | Image Assessment Using Computed Tomography (CT) | Reduction position changed | 6 Participants |
| ZNN CM Asia Without AS2 Technique | Image Assessment Using Computed Tomography (CT) | Reduction position maintained | 92 Participants |
| ZNN CM Asia Without AS2 Technique | Image Assessment Using Computed Tomography (CT) | Reduction position changed | 21 Participants |
Secondary
Intraoperative Safety
This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.
Time frame: Intraoperative
Population: Intent-to-treat group
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ZNN CM Asia With AS2 Technique | Intraoperative Safety | No adverse event | 121 Participants |
| ZNN CM Asia With AS2 Technique | Intraoperative Safety | adverse event | 0 Participants |
| ZNN CM Asia Without AS2 Technique | Intraoperative Safety | No adverse event | 119 Participants |
| ZNN CM Asia Without AS2 Technique | Intraoperative Safety | adverse event | 0 Participants |
Secondary
Surgery Time
Surgery time from skin incision to closure
Time frame: Intraoperative, an average of 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZNN CM Asia With AS2 Technique | Surgery Time | 68.2 minutes | Standard Deviation 21.8 |
| ZNN CM Asia Without AS2 Technique | Surgery Time | 59.8 minutes | Standard Deviation 20.9 |