Trial Outcomes & Findings for CM Asia Nail With AS2 Without AS2 （AS2 Study） (NCT NCT03196193)
NCT ID: NCT03196193
Last Updated: 2020-09-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Postoperative 2-3 week
Results posted on
2020-09-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
119
|
|
Overall Study
COMPLETED
|
118
|
119
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Computed Tomography (CT) data missing
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ZNN CM Asia With AS2 Technique
n=118 Participants
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.
|
ZNN CM Asia Without AS2 Technique
n=119 Participants
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.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
85.9 years
STANDARD_DEVIATION 8.9 • n=118 Participants
|
86.7 years
STANDARD_DEVIATION 7.9 • n=119 Participants
|
86.3 years
STANDARD_DEVIATION 8.4 • n=237 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=118 Participants
|
97 Participants
n=119 Participants
|
200 Participants
n=237 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=118 Participants
|
22 Participants
n=119 Participants
|
37 Participants
n=237 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
118 participants
n=118 Participants
|
119 participants
n=119 Participants
|
237 participants
n=237 Participants
|
|
Height
|
148.9 cm
STANDARD_DEVIATION 8.8 • n=118 Participants
|
150.0 cm
STANDARD_DEVIATION 9.0 • n=119 Participants
|
149.4 cm
STANDARD_DEVIATION 8.9 • n=237 Participants
|
|
Weight
|
45.3 kg
STANDARD_DEVIATION 9.8 • n=118 Participants
|
46.2 kg
STANDARD_DEVIATION 9.3 • n=119 Participants
|
45.8 kg
STANDARD_DEVIATION 9.6 • n=237 Participants
|
PRIMARY outcome
Timeframe: Postoperative 2-3 weekNumber 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.
Outcome measures
| Measure |
ZNN CM Asia With AS2 Technique
n=118 Participants
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.
|
ZNN CM Asia Without AS2 Technique
n=119 Participants
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.
|
|---|---|---|
|
Number of Patient With and Without Excessive Lag Screw Sliding Distance
Success (lag screw sliding distance <4mm)
|
109 Participants
|
97 Participants
|
|
Number of Patient With and Without Excessive Lag Screw Sliding Distance
Failure (lag screw sliding distance >=4mm)
|
9 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Intraoperative, an average of 1 hourSurgery time from skin incision to closure
Outcome measures
| Measure |
ZNN CM Asia With AS2 Technique
n=118 Participants
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.
|
ZNN CM Asia Without AS2 Technique
n=119 Participants
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.
|
|---|---|---|
|
Surgery Time
|
68.2 minutes
Standard Deviation 21.8
|
59.8 minutes
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: 2-3 weeks postoperativelyPopulation: 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".)
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).
Outcome measures
| Measure |
ZNN CM Asia With AS2 Technique
n=110 Participants
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.
|
ZNN CM Asia Without AS2 Technique
n=113 Participants
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.
|
|---|---|---|
|
Image Assessment Using Computed Tomography (CT)
Reduction position maintained
|
104 Participants
|
92 Participants
|
|
Image Assessment Using Computed Tomography (CT)
Reduction position changed
|
6 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: IntraoperativePopulation: Intent-to-treat group
This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.
Outcome measures
| Measure |
ZNN CM Asia With AS2 Technique
n=121 Participants
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.
|
ZNN CM Asia Without AS2 Technique
n=119 Participants
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.
|
|---|---|---|
|
Intraoperative Safety
No adverse event
|
121 Participants
|
119 Participants
|
|
Intraoperative Safety
adverse event
|
0 Participants
|
0 Participants
|
Adverse Events
ZNN CM Asia With AS2 Technique
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
ZNN CM Asia Without AS2 Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZNN CM Asia With AS2 Technique
n=121 participants at risk
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.
|
ZNN CM Asia Without AS2 Technique
n=119 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Cut-out
|
0.83%
1/121 • Number of events 1 • 3 weeks after surgery
|
0.00%
0/119 • 3 weeks after surgery
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Manager of Clinical Affairs
Zimmer Biomet G.K.
Phone: +81-3-6402-6610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place