Trial Outcomes & Findings for A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture (NCT NCT04462172)
NCT ID: NCT04462172
Last Updated: 2026-07-20
Results Overview
defined as the total incidence of internal plant cut-out and fracture.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
290 participants
Primary outcome timeframe
from operation to 1-year follow-up after the surgery
Results posted on
2026-07-20
Participant Flow
A total of 358 patients with femoral neck fractures at seven hospitals were initially recruited and screened for eligibility to participate in the study from October 2021 to November 2023. Of these patients, 68 patients were excluded from this study. Ultimately, 290 patients were enrolled for the study.
This is a prospective cohort study. All patients were independently choosing to join in one of the 2 groups. We used FNS for internal fixation in FNS group, while we did the internal fixation with MCS in MCS group. Enrollment stoped after either group reaches 145 cases, and the enrollment completed after both groups reach 145 cases.
Participant milestones
| Measure |
Synthes Femoral Neck System (FNS)
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
145
|
|
Overall Study
COMPLETED
|
139
|
138
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture
Baseline characteristics by cohort
| Measure |
Synthes Femoral Neck System (FNS)
n=139 Participants
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 Participants
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
Total
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.71 years
STANDARD_DEVIATION 11.41 • n=20 Participants
|
52.01 years
STANDARD_DEVIATION 11.88 • n=20 Participants
|
52.86 years
STANDARD_DEVIATION 11.65 • n=40 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=20 Participants
|
65 Participants
n=20 Participants
|
137 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=20 Participants
|
73 Participants
n=20 Participants
|
140 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
139 Participants
n=20 Participants
|
138 Participants
n=20 Participants
|
277 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Garden classification
I-II
|
50 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
111 Participants
n=40 Participants
|
|
Garden classification
III-IV
|
89 Participants
n=20 Participants
|
77 Participants
n=20 Participants
|
166 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: from operation to 1-year follow-up after the surgerydefined as the total incidence of internal plant cut-out and fracture.
Outcome measures
| Measure |
Synthes Femoral Neck System (FNS)
n=139 Participants
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 Participants
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
Internal Fixation Failure Rate
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: from operation to 1-year follow-up after the surgeryevaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months, it is defined as nonunion.
Outcome measures
| Measure |
Synthes Femoral Neck System (FNS)
n=139 Participants
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 Participants
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
Number of Participants With Bone Nonunion
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At 1 year after the surgerythe scale of the score value is from 0 to 100, and a higher score means a better outcome
Outcome measures
| Measure |
Synthes Femoral Neck System (FNS)
n=139 Participants
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 Participants
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
Harris Hip Score
|
92.59 point
Standard Deviation 3.87
|
89.44 point
Standard Deviation 6.66
|
SECONDARY outcome
Timeframe: intraoperativefrom the incision to internal fixation implanted.
Outcome measures
| Measure |
Synthes Femoral Neck System (FNS)
n=139 Participants
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 Participants
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
Operation Time
|
55.76 minutes
Standard Deviation 9.25
|
63.86 minutes
Standard Deviation 9.37
|
SECONDARY outcome
Timeframe: intraoperativeaverage 25 milliseconds per X-ray shot, record the number of X-ray shot
Outcome measures
| Measure |
Synthes Femoral Neck System (FNS)
n=139 Participants
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 Participants
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
The Times of Intraoperative Fluoroscopy
|
12.32 count of x-ray images
Standard Deviation 3.25
|
18.49 count of x-ray images
Standard Deviation 5.09
|
SECONDARY outcome
Timeframe: from operation to 1-year follow-up after the surgeryincluding ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening
Outcome measures
| Measure |
Synthes Femoral Neck System (FNS)
n=139 Participants
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 Participants
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
Number of Participants With Postoperative Adverse Events
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: from operation to 1-year follow-up after the surgeryRoutine radiographs were taken to assess fracture reduction quality, which was categorized neutral, positive or negative support. Neutral Support: the medial cortex of the head-neck fragment is continuous with the medial cortex of the femoral shaft. Positive support: the medial cortex of the head-neck fragment lies medial to the medial cortex of the femoral shaft. Negative support: the medial cortex of the head-neck fragment lies lateral to the medial cortex of the femoral shaft.
Outcome measures
| Measure |
Synthes Femoral Neck System (FNS)
n=139 Participants
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 Participants
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
Reduction Quality
Positive support
|
67 Participants
|
65 Participants
|
|
Reduction Quality
Neutral support
|
26 Participants
|
29 Participants
|
|
Reduction Quality
Negative support
|
46 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: from operation to 1-year follow-up after the surgerySince both implants are designed to allow for femoral neck shortening to allow fragment contact and bone healing. The amount of shortening primarily depends on the fracture configuration and bone quality.
Outcome measures
| Measure |
Synthes Femoral Neck System (FNS)
n=139 Participants
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 Participants
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
Femoral Neck Shortening
|
3.61 mm
Standard Deviation 2.30
|
4.09 mm
Standard Deviation 2.66
|
Adverse Events
Synthes Femoral Neck System (FNS)
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
Multiple Cancellous Screws (MCS)
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synthes Femoral Neck System (FNS)
n=139 participants at risk
Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.
|
Multiple Cancellous Screws (MCS)
n=138 participants at risk
Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Avascular necrosis
|
2.2%
3/139 • from enrollment until post operation 1 year of follow-up
|
3.6%
5/138 • from enrollment until post operation 1 year of follow-up
|
|
Injury, poisoning and procedural complications
Fracture nonunion
|
0.72%
1/139 • from enrollment until post operation 1 year of follow-up
|
0.00%
0/138 • from enrollment until post operation 1 year of follow-up
|
|
Injury, poisoning and procedural complications
Implant cutout
|
2.2%
3/139 • from enrollment until post operation 1 year of follow-up
|
2.2%
3/138 • from enrollment until post operation 1 year of follow-up
|
|
Injury, poisoning and procedural complications
Implant lateral protrusion
|
0.00%
0/139 • from enrollment until post operation 1 year of follow-up
|
2.9%
4/138 • from enrollment until post operation 1 year of follow-up
|
|
Blood and lymphatic system disorders
Die due to lymphoma
|
0.72%
1/139 • from enrollment until post operation 1 year of follow-up
|
0.00%
0/138 • from enrollment until post operation 1 year of follow-up
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place