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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLS stem | CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning |
| |
| Wagner cone stem | Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning |
| |
| Aptafix stem | Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip stem | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 |
| 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 | Day 0 |
| 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 | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 |
| Combined Anteversion Wagner Cone |
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Inclusion Criteria:
Exclusion Criteria:
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A random population of 200 CT scans (from the fourth lumbar vertebra to the tibial plateaus) involving adult patients with developmental hip dysplasia.
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Traina, Professor | IRCCS Istituto Ortopedico Rizzoli | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28110848 | Background | Taniguchi N, Jinno T, Koga D, Hagino T, Okawa A, Haro H. Cementless Hip Stem Anteversion in the Dysplastic Hip: A Comparison of Tapered Wedge vs Metaphyseal Filling. J Arthroplasty. 2017 May;32(5):1547-1552. doi: 10.1016/j.arth.2016.12.020. Epub 2016 Dec 22. | |
| 16129740 | Background | Argenson JN, Ryembault E, Flecher X, Brassart N, Parratte S, Aubaniac JM. Three-dimensional anatomy of the hip in osteoarthritis after developmental dysplasia. J Bone Joint Surg Br. 2005 Sep;87(9):1192-6. doi: 10.1302/0301-620X.87B9.15928. |
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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.
Random selection of pre-operative Ct including native dysplastic hips
| ID | Title | Description |
|---|---|---|
| FG000 | 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, Wagner Cone Zimmer, Aptafix Adler |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All the 150 patients enrolled in the study underwent a preoperative planning with a particular software, and every eligible dysplastic hip (200) was studied with three different stem design
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| 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 | 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 | Posted | Count of Units | Hips | Day 0 | Hips | Hips |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not assessed
No adverse events were reported, results of the article are based on a prosthetic implants planning software performed on CT scan images.
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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 | CLS Stem | CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francesco Castagnini, MD | IRCCS Istituto Ortopedico Rizzoli | +390516366418 | francesco.castagnini@ior.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2021 | Sep 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| D000082602 | Developmental Dysplasia of the Hip |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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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 |
| Day 0 |
| 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 | Day 0 |
| 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 | Day 0 |
| 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 | Day 0 |
| 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 | Day 0 |
| 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 | Day 0 |
| 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 | Day 0 |
| 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 | Day 0 |
| 22569720 | Background | Sugano N, Takao M, Sakai T, Nishii T, Miki H. Does CT-based navigation improve the long-term survival in ceramic-on-ceramic THA? Clin Orthop Relat Res. 2012 Nov;470(11):3054-9. doi: 10.1007/s11999-012-2378-4. |
| 30612885 | Background | Castagnini F, Valente G, Crimi G, Taddei F, Bordini B, Stea S, Toni A. Component positioning and ceramic damage in cementless ceramic-on-ceramic total hip arthroplasty. J Orthop Sci. 2019 Jul;24(4):643-651. doi: 10.1016/j.jos.2018.12.011. Epub 2019 Jan 4. |
| Hips |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | 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. | Number | hips | Participants |
|
| height | Mean | Standard Deviation | centimeters | Participants |
|
| weight | Mean | Standard Deviation | kg | Participants |
|
| BMI | Mean | Standard Deviation | kg/m² | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Posted | Count of Units | Hips | Day 0 | Hips | Hips |
|
|
|
| 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 | Posted | Count of Units | Hips | Day 0 | Hips | 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 | Posted | Count of Units | Hips | Day 0 | Hips | 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 | Posted | Count of Units | Hips | Day 0 | Hips | 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 | Posted | Count of Units | Hips | Day 0 | Hips | 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 | Posted | Count of Units | Hips | Day 0 | Hips | 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 | Posted | Count of Units | Hips | Day 0 | Hips | 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 | Posted | Count of Units | Hips | Day 0 | Hips | 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 | Posted | Count of Units | Hips | Day 0 | Hips | 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 | Posted | Count of Units | Hips | Day 0 | Hips | 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 | Posted | Count of Units | Hips | Day 0 | Hips | Hips |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Wagner Cone Stem | Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Aptafix Stem | Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D025981 |
| Hip Injuries |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |