Trial Outcomes & Findings for Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position (NCT NCT02664272)
NCT ID: NCT02664272
Last Updated: 2019-07-15
Results Overview
Difference D was measured using standardized fluoroscopic images taken during surgery. Investigators also reported any stem position corrections made as well as type of rasping instrument used. The difference D is given in millimeters (mm) and is defined as D = x1 - x2 with x1 being the distance between the shoulder of the trial rasp and the tip of the greater trochanter and x2 being the distance between the shoulder of the implant and the tip of the greater trochanter.
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
Intraoperative examination only
Results posted on
2019-07-15
Participant Flow
Unit of analysis: Unit=hips (SL-PLUS™ MIA Ti/HA stems)
Participant milestones
| Measure |
SL-PLUS™ MIA Ti/HA
Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
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|---|---|
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Overall Study
STARTED
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40 41
|
|
Overall Study
COMPLETED
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38 39
|
|
Overall Study
NOT COMPLETED
|
2 2
|
Reasons for withdrawal
| Measure |
SL-PLUS™ MIA Ti/HA
Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
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|---|---|
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Overall Study
Fluoroscopic images not made available
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2
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Baseline Characteristics
Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position
Baseline characteristics by cohort
| Measure |
SL-PLUS™ MIA Ti/HA
n=41 hips
Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
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|---|---|
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Age, Continuous
|
71.84 years
STANDARD_DEVIATION 9.393 • n=41 hips
|
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Sex: Female, Male
Female
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25 hips
n=41 hips
|
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Sex: Female, Male
Male
|
16 hips
n=41 hips
|
|
Region of Enrollment
Germany
|
21 hips
n=41 hips
|
|
Region of Enrollment
Austria
|
20 hips
n=41 hips
|
|
Operated Side
Left
|
18 hips
n=41 hips
|
|
Operated Side
Right
|
23 hips
n=41 hips
|
|
Height (cm)
|
167.68 centimeters
STANDARD_DEVIATION 9.237 • n=41 hips
|
|
Weight (kg)
|
77.71 kilograms
STANDARD_DEVIATION 15.837 • n=41 hips
|
|
BMI (kg/m^2)
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27.47 kg/m^2
STANDARD_DEVIATION 4.270 • n=41 hips
|
|
Primary diagnosis for total hip arthroplasty
Osteoarthritis
|
36 hips
n=41 hips
|
|
Primary diagnosis for total hip arthroplasty
Rheumatoid arthritis
|
0 hips
n=41 hips
|
|
Primary diagnosis for total hip arthroplasty
Post-traumatic arthritis
|
0 hips
n=41 hips
|
|
Primary diagnosis for total hip arthroplasty
Avascular necrosis
|
2 hips
n=41 hips
|
|
Primary diagnosis for total hip arthroplasty
Dysplasia
|
3 hips
n=41 hips
|
|
Primary diagnosis for total hip arthroplasty
Fracture
|
0 hips
n=41 hips
|
|
Primary diagnosis for total hip arthroplasty
Other
|
0 hips
n=41 hips
|
|
Dorr classification of femoral bone type
Type A
|
3 hips
n=41 hips
|
|
Dorr classification of femoral bone type
Type B
|
32 hips
n=41 hips
|
|
Dorr classification of femoral bone type
Type C
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6 hips
n=41 hips
|
|
Intraoperative used stem type
Standard
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34 hips
n=41 hips
|
|
Intraoperative used stem type
Lateral
|
7 hips
n=41 hips
|
|
Intraoperative used stem size
Size 01
|
0 hips
n=41 hips
|
|
Intraoperative used stem size
Size 00
|
3 hips
n=41 hips
|
|
Intraoperative used stem size
Size 1
|
1 hips
n=41 hips
|
|
Intraoperative used stem size
Size 2
|
3 hips
n=41 hips
|
|
Intraoperative used stem size
Size 3
|
5 hips
n=41 hips
|
|
Intraoperative used stem size
Size 4
|
10 hips
n=41 hips
|
|
Intraoperative used stem size
Size 5
|
10 hips
n=41 hips
|
|
Intraoperative used stem size
Size 6
|
8 hips
n=41 hips
|
|
Intraoperative used stem size
Size 7
|
1 hips
n=41 hips
|
PRIMARY outcome
Timeframe: Intraoperative examination onlyDifference D was measured using standardized fluoroscopic images taken during surgery. Investigators also reported any stem position corrections made as well as type of rasping instrument used. The difference D is given in millimeters (mm) and is defined as D = x1 - x2 with x1 being the distance between the shoulder of the trial rasp and the tip of the greater trochanter and x2 being the distance between the shoulder of the implant and the tip of the greater trochanter.
Outcome measures
| Measure |
SL-PLUS™ MIA Ti/HA
n=39 hips
Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
|
|---|---|
|
Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement
Difference D
|
2.63 mm
Interval 1.89 to 3.37
|
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Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement
Distance X1 (trial rasp)(mm)
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7.78 mm
Interval 6.15 to 9.4
|
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Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement
Distance X2 (stem)(mm)
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5.15 mm
Interval 3.52 to 6.78
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SECONDARY outcome
Timeframe: Preoperative, directly postoperative (approximately 3 months)Leg length discrepancy was measured preoperatively and postoperatively shortly after insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem.
Outcome measures
| Measure |
SL-PLUS™ MIA Ti/HA
n=41 hips
Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
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|---|---|
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Number of Hips With Leg Length Discrepancy
Leg Length Discrepancy (preoperative) · No Discrepancy
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24 hips
|
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Number of Hips With Leg Length Discrepancy
Leg Length Discrepancy (preoperative) · Ipsilateral Longer (mm)
|
1 hips
|
|
Number of Hips With Leg Length Discrepancy
Leg Length Discrepancy (preoperative) · Ipsilateral Shorter (mm)
|
16 hips
|
|
Number of Hips With Leg Length Discrepancy
Leg Length Discrepancy (postoperative) · No Discrepancy
|
36 hips
|
|
Number of Hips With Leg Length Discrepancy
Leg Length Discrepancy (postoperative) · Ipsilateral Longer (mm)
|
1 hips
|
|
Number of Hips With Leg Length Discrepancy
Leg Length Discrepancy (postoperative) · Ipsilateral Shorter (mm)
|
4 hips
|
SECONDARY outcome
Timeframe: Intraoperative examination onlyIntraoperative complications were collected as a secondary outcome.
Outcome measures
| Measure |
SL-PLUS™ MIA Ti/HA
n=41 hips
Subjects received the SL-PLUS™ MIA Ti/HA femoral hip stem and were examined using intraoperative fluoroscopic images to determine any differences between the final position of the femoral stem and the last trial rasp position. Secondarily, subjects were evaluated for leg length discrepancies preoperatively and postoperatively following insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem as well as any intraoperative complications.
|
|---|---|
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Number of Hips With Intraoperative Complications
Adverse Events (AEs)
|
0 hips
|
|
Number of Hips With Intraoperative Complications
Serious Adverse Events (SAEs)
|
0 hips
|
Adverse Events
SL-PLUS™ MIA Ti/HA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vice President of Medical Affairs
Smith & Nephew, Inc.
Phone: +41 41 7662222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator must submit results for any proposed publication to the sponsor at least 60 days before the submission. All publications will include any comments by the sponsor to modify publication for any potentially patentable item, trade secret, proprietary right, or confidential information of the sponsor. Any publication based on the results obtained from the site (or group of sites) shall not be made before the first multicenter publication.
- Publication restrictions are in place
Restriction type: OTHER