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A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.
The study objective was to evaluate if there was a difference between the femoral position of the last trial rasp and the final implant position of the SL-PLUS™ MIA Ti/HA femoral hip stem. The femoral position of rasp or stem was considered as the height of the implant / rasp in cranio-caudal direction.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | Intraoperative examination only |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hips With Leg Length Discrepancy | Leg length discrepancy was measured preoperatively and postoperatively shortly after insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem. | Preoperative, directly postoperative (approximately 3 months) |
| Number of Hips With Intraoperative Complications |
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Inclusion Criteria:
Patient:
Exclusion Criteria:
Patient:
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Patients enrolled in this multicenter clinical observation had at least one of the indications listed below and met all of the inclusion criteria. Patients who met any of the exclusion criteria were not eligible for this study.
Indications:
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| Name | Affiliation | Role |
|---|---|---|
| Andy Weymann, MD, MBA | Smith & Nephew Orthopaedics AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Orthopädie, PMU Salzburg | Salzburg | Austria | ||||
| Charité Universitätsmedizin Berlin Centrum für Muskuloskeletale Chirurgie Klinik für Orthopädie |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 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. | Posted | Mean | 95% Confidence Interval | mm | Intraoperative examination only | hips | hips |
|
Adverse events were collected from the time of preoperative examinations (Baseline) until directly postoperatively (time frame of approximately 3 months enrollment period).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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Basic fluoroscopic image analysis (intrinsic: resolution/technique and extrinsic: alignment/orientation to landmarks). The Guide to the Expression of Uncertainty in Measurement (GUM) was followed to estimate the combined uncertainty of the method.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Medical Affairs | Smith & Nephew, Inc. | +41 41 7662222 | luca.orlandini@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2015 | Oct 18, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2017 | Oct 18, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Intraoperative complications were collected as a secondary outcome. |
| Intraoperative examination only |
| Berlin |
| Germany |
| Orthopädische Chirurgie München | Munich | Germany |
| hips |
|
| years |
| hips |
|
|
| Sex: Female, Male | Count of Units | hips | hips |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | hips | hips |
|
|
| Operated Side | Count of Units | hips | hips |
|
|
| Height (cm) | Mean | Standard Deviation | centimeters | hips |
|
|
| Weight (kg) | Mean | Standard Deviation | kilograms | hips |
|
|
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 | hips |
|
|
| Primary diagnosis for total hip arthroplasty | Count of Units | hips | hips |
|
|
| Dorr classification of femoral bone type | Dorr Classification of femoral bone type: Type A: narrow canal with thick cortical walls (champagne flute canal); femoral canal width (FW)/calcar width (CW) <50%. Type B: moderate cortical walls; FW/CW = 50-90%. Type C: wide canal with thin cortical walls (stove-pipe canal); FW/CW >90%. The canal-to-calcar ratio is a reflection of the geometric relationship of 2 points of the proximal femoral canal. A smaller ratio represents a funnel shape and a larger ratio is a more cylindrical or stove-pipe shape. | Count of Units | hips | hips |
|
|
| Intraoperative used stem type | Count of Units | hips | hips |
|
|
| Intraoperative used stem size | Count of Units | hips | hips |
|
|
|
|
| Secondary | Number of Hips With Leg Length Discrepancy | Leg length discrepancy was measured preoperatively and postoperatively shortly after insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem. | Posted | Count of Units | hips | Preoperative, directly postoperative (approximately 3 months) | hips | hips |
|
|
|
| Secondary | Number of Hips With Intraoperative Complications | Intraoperative complications were collected as a secondary outcome. | Posted | Count of Units | hips | Intraoperative examination only | hips | hips |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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.
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| Dysplasia |
|
| Fracture |
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| Other |
|
| Size 3 |
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| Size 4 |
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| Size 5 |
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| Size 6 |
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| Size 7 |
|
| Leg Length Discrepancy (postoperative) |
|