Dysplasia; Hip
Conditions
Keywords
Hip arthroplasty, Hip stem, Pre-operative planning, Combined anteversion, Offset, Developmental dysplasia of the hip
Brief summary
A random population of 200 CT scans of pelvis and thigh in an adult population affected by hip dysplasia will be selected. The aim of this study is to evaluate the biomechanical reconstruction of the hip anatomy provided by three different hip stem designs in dysplastic cases, using a 3D CT based software for pre-operative planning.
Detailed description
Pre-operative planning in hip arthroplasty with dedicated software is a useful guide to provide a better reconstruction of the biomechanical parameters of the replaced hip and to optimize the choice of component, improving the geometric understanding of the hip anatomy and the interaction between the native morphological structure and the prosthetic component. The use of a 3D CT-based software for pre-operative planning may provide a better knowledge of the hip anatomy, simulating the biomechanical parameters more closely than a 2D X-ray-based software. In addition, it is the only way to anticipate the correct interaction between the prosthetic components, or the combined anteversion, a key factor in preventing implant instability. Severe hip deformities, like developmental hip dysplasia, may not be adequately reconstructed by every implant and 3D pre-operative CT may increase the three-dimensional anatomical knowledge of the hip, improving the choice of the correct implant and possibly reducing the possible consequences of intra and post-operative complications. Therefore, the purpose of this study is to pre-operatively plan, in a random series of 200 native pelvis and thigh CT scans performed in patients with hip dysplasia, 3 different types of hip stem designs using the 3D Hip-Op software, with the aim of analyzing, on the CT simulations, the percentage of adequate reconstruction of the optimal biomechanical parameters (combined anteversion between 25°-50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80%). The percentage of every stem design providing the optimal reconstruction in dysplastic hips (all the 5 parameters matched) will be assessed. The single parameters, especially the combined anteversion, the offset restoration and the leg lengthening, will be assessed for every simulation.
Interventions
DEVICEHip stem
In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* definition of developmental hip dysplasia according to Wiberg (center edge angle \<20°) * pre-operative CT scan extended from the fourth lumbar vertebra to the tibial plateaus
Exclusion criteria
* other types of hip pathologies * inadequate Ct scans
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct Reconstruction CLS | Day 0 | Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time). Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 the worst |
| Correct Reconstruction Wagner Cone | Day 0 | Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time). Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 the worst |
| Correct Reconstruction Aptafix | Day 0 | Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time). Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 the worst |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Offset CLS | Day 0 | Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst |
| Offset Wagner Cone | Day 0 | Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst |
| Offset Aptafix | Day 0 | Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst |
| Combined Anteversion CLS | Day 0 | Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (\<37°) using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst |
| Leg Lengthening Wagner Cone | Day 0 | Percentage of hips with leg lengthening not superior to 3 cm using CLS stems. Minimum-maximum values (as percentages %): 0-100. 100 is the best result, 0 is the worst |
| Leg Lengthening Aptafix | Day 0 | Percentage of hips with leg lengthening not superior to 3 cm using CLS stems. Minimum-maximum values (as percentages %): 0-100. 100 is the best result, 0 is the worst |
| Leg Lengthening CLS | Day 0 | Percentage of hips with leg lengthening not superior to 3 cm using CLS stems. Minimum-maximum values (as percentages %): 0-100. 100 is the best result, 0 is the worst |
| Combined Anteversion Wagner Cone | Day 0 | Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (\<37°) using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst |
| Combined Anteversion Aptafix | Day 0 | Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (\<37°) using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst |
Countries
Italy
Participant flow
Recruitment details
Random selection of pre-operative Ct including native dysplastic hips
Pre-assignment details
All the 150 patients enrolled in the study underwent a preoperative planning with a particular software, and each hip (200) was studied with three different stem design, so each of them results enrolled in each arm group which represents a different kind of hip stem.
Participants by arm
| Arm | Count |
|---|---|
| Simulated Hips Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning. The three stems are: CLS Zimmer (single wedge, tapered stem), Wagner Cone Zimmer (tapered stem), Aptafix Adler (anatomical stem) | 150 |
| Simulated Hips Hip stem: In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning. The three stems are: CLS Zimmer (single wedge, tapered stem), Wagner Cone Zimmer (tapered stem), Aptafix Adler (anatomical stem) | 200 |
| Total | 350 |
Baseline characteristics
| Characteristic | Simulated Hips |
|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 11 |
| BMI | 25.8 kg/m² STANDARD_DEVIATION 4.9 |
| height | 159.8 centimeters STANDARD_DEVIATION 18.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 150 Participants |
| Region of Enrollment Italy | 150 hips |
| Sex: Female, Male Female | 115 Participants |
| Sex: Female, Male Male | 35 Participants |
| weight | 66.1 kg STANDARD_DEVIATION 15.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Correct Reconstruction Aptafix
Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time). Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Correct Reconstruction Aptafix | 88 Hips |
Primary
Correct Reconstruction CLS
Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time). Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Correct Reconstruction CLS | 138 Hips |
Primary
Correct Reconstruction Wagner Cone
Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time). Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Correct Reconstruction Wagner Cone | 174 Hips |
Secondary
Combined Anteversion Aptafix
Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (\<37°) using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Combined Anteversion Aptafix | 121 Hips |
Secondary
Combined Anteversion CLS
Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (\<37°) using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Combined Anteversion CLS | 153 Hips |
Secondary
Combined Anteversion Wagner Cone
Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (\<37°) using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Combined Anteversion Wagner Cone | 197 Hips |
Secondary
Leg Lengthening Aptafix
Percentage of hips with leg lengthening not superior to 3 cm using CLS stems. Minimum-maximum values (as percentages %): 0-100. 100 is the best result, 0 is the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Leg Lengthening Aptafix | 183 Hips |
Secondary
Leg Lengthening CLS
Percentage of hips with leg lengthening not superior to 3 cm using CLS stems. Minimum-maximum values (as percentages %): 0-100. 100 is the best result, 0 is the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Leg Lengthening CLS | 188 Hips |
Secondary
Leg Lengthening Wagner Cone
Percentage of hips with leg lengthening not superior to 3 cm using CLS stems. Minimum-maximum values (as percentages %): 0-100. 100 is the best result, 0 is the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Leg Lengthening Wagner Cone | 194 Hips |
Secondary
Offset Aptafix
Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Offset Aptafix | 164 Hips |
Secondary
Offset CLS
Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Offset CLS | 192 Hips |
Secondary
Offset Wagner Cone
Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems. Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 is the worst
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CLS Stem | Offset Wagner Cone | 186 Hips |