Osteoarthritis
Conditions
Brief summary
A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.
Detailed description
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.
Interventions
PROCEDURETotal Hip Arthroplasty
Sponsors
Smith & Nephew Orthopaedics AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient: * requires primary THA with the SL-PLUS™ MIA Ti/HA femoral hip stem * is at least 21 years of age at the time of surgery * is skeletally mature in the PI's judgment * has consented to participate in the study by signing the EC approved ICF
Exclusion criteria
Patient: * requires the use of a ceramic-on-ceramic bearing * has infections, acute or chronic, local or systemic * has severe muscle, nerve or vascular diseases that endanger the respective limb * has lack of bone substance or defective bone quality that jeopardizes the stable seating of the prosthesis * has any concomitant disease that may jeopardize implant function * has a known allergy to study device or one or more of its components * requires a revision surgery and has extensive bone defects * has diagnosis of an immunosuppressive disorder * is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Intraoperative examination only | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hips With Leg Length Discrepancy | 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. |
| Number of Hips With Intraoperative Complications | Intraoperative examination only | Intraoperative complications were collected as a secondary outcome. |
Countries
Austria, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 41 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Fluoroscopic images not made available | 2 |
Baseline characteristics
| Characteristic | SL-PLUS™ MIA Ti/HA |
|---|---|
| Age, Continuous | 71.84 years STANDARD_DEVIATION 9.393 |
| BMI (kg/m^2) | 27.47 kg/m^2 STANDARD_DEVIATION 4.27 |
| Dorr classification of femoral bone type Type A | 3 hips |
| Dorr classification of femoral bone type Type B | 32 hips |
| Dorr classification of femoral bone type Type C | 6 hips |
| Height (cm) | 167.68 centimeters STANDARD_DEVIATION 9.237 |
| Intraoperative used stem size Size 00 | 3 hips |
| Intraoperative used stem size Size 01 | 0 hips |
| Intraoperative used stem size Size 1 | 1 hips |
| Intraoperative used stem size Size 2 | 3 hips |
| Intraoperative used stem size Size 3 | 5 hips |
| Intraoperative used stem size Size 4 | 10 hips |
| Intraoperative used stem size Size 5 | 10 hips |
| Intraoperative used stem size Size 6 | 8 hips |
| Intraoperative used stem size Size 7 | 1 hips |
| Intraoperative used stem type Lateral | 7 hips |
| Intraoperative used stem type Standard | 34 hips |
| Operated Side Left | 18 hips |
| Operated Side Right | 23 hips |
| Primary diagnosis for total hip arthroplasty Avascular necrosis | 2 hips |
| Primary diagnosis for total hip arthroplasty Dysplasia | 3 hips |
| Primary diagnosis for total hip arthroplasty Fracture | 0 hips |
| Primary diagnosis for total hip arthroplasty Osteoarthritis | 36 hips |
| Primary diagnosis for total hip arthroplasty Other | 0 hips |
| Primary diagnosis for total hip arthroplasty Post-traumatic arthritis | 0 hips |
| Primary diagnosis for total hip arthroplasty Rheumatoid arthritis | 0 hips |
| Region of Enrollment Austria | 20 hips |
| Region of Enrollment Germany | 21 hips |
| Sex: Female, Male Female | 25 hips |
| Sex: Female, Male Male | 16 hips |
| Weight (kg) | 77.71 kilograms STANDARD_DEVIATION 15.837 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: Intraoperative examination only
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SL-PLUS™ MIA Ti/HA | 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) | 7.78 mm |
| SL-PLUS™ MIA Ti/HA | 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) | 5.15 mm |
| SL-PLUS™ MIA Ti/HA | 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 |
Secondary
Number of Hips With Intraoperative Complications
Intraoperative complications were collected as a secondary outcome.
Time frame: Intraoperative examination only
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SL-PLUS™ MIA Ti/HA | Number of Hips With Intraoperative Complications | Adverse Events (AEs) | 0 hips |
| SL-PLUS™ MIA Ti/HA | Number of Hips With Intraoperative Complications | Serious Adverse Events (SAEs) | 0 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.
Time frame: Preoperative, directly postoperative (approximately 3 months)
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| SL-PLUS™ MIA Ti/HA | Number of Hips With Leg Length Discrepancy | Leg Length Discrepancy (preoperative) | No Discrepancy | 24 hips |
| SL-PLUS™ MIA Ti/HA | Number of Hips With Leg Length Discrepancy | Leg Length Discrepancy (preoperative) | Ipsilateral Longer (mm) | 1 hips |
| SL-PLUS™ MIA Ti/HA | Number of Hips With Leg Length Discrepancy | Leg Length Discrepancy (preoperative) | Ipsilateral Shorter (mm) | 16 hips |
| SL-PLUS™ MIA Ti/HA | Number of Hips With Leg Length Discrepancy | Leg Length Discrepancy (postoperative) | No Discrepancy | 36 hips |
| SL-PLUS™ MIA Ti/HA | Number of Hips With Leg Length Discrepancy | Leg Length Discrepancy (postoperative) | Ipsilateral Longer (mm) | 1 hips |
| SL-PLUS™ MIA Ti/HA | Number of Hips With Leg Length Discrepancy | Leg Length Discrepancy (postoperative) | Ipsilateral Shorter (mm) | 4 hips |