CTdevice: Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software

• Sponsor: Istituto Ortopedico Rizzoli (Other)
• Overall Status: Completed
• CT.gov ID: NCT04904640
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 74.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysplasia; Hip	Device: Hip stem

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Evaluation of the Reconstruction of Biomechanical Parameters Provided by Three Different Hip Stem Designs in Developmental Hip Dysplasia Using a 3D CT-based Software for Surgical Planning
• Actual Study Start Date: May 10, 2021
• Actual Primary Completion Date: Jul 10, 2021
• Actual Study Completion Date: Jul 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
CLS stem CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning	Device: 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.
Wagner cone stem Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning	Device: 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.
Aptafix stem Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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 Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy	Bologna		Italy	40136

Sponsors and Collaborators

• Istituto Ortopedico Rizzoli

Investigators

• Study Director: Francesco Traina, Professor, IRCCS Istituto Ortopedico Rizzoli

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 14, 2021

More Information

Additional Information:

• Hip Op software used for surgical pre-operative planning

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT04904640
• Other Study ID Numbers: 29/2021/Oss/IOR
• First Posted: May 27, 2021
• Last Update Posted: Sep 9, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Istituto Ortopedico Rizzoli: Hip arthroplasty; Hip stem; Pre-operative planning; Combined anteversion; Offset; Developmental dysplasia of the hip
• Additional relevant MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Hyperplasia

Study Results

Participant Flow

Recruitment Details	Random selection of pre-operative Ct including native dysplastic hips
Pre-assignment Detail	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.

Arm/Group Title	Simulated Hips
Arm/Group Description	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
Period Title: Overall Study
STARTED	150
COMPLETED	150
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Simulated Hips
Arm/Group Description	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)
Overall Participants	150
Overall Hips	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.8 (11)
Sex: Female, Male (Count of Participants)
Female	115 76.7%
Male	35 23.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	150 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (hips) [Number]
Italy	150
height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	159.8 (18.3)
weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	66.1 (15.3)
BMI (kg/m²) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m²]	25.8 (4.9)

Outcome Measures

1. Primary Outcome

Title	Correct Reconstruction CLS
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CLS Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	138

2. Primary Outcome

Title	Correct Reconstruction Wagner Cone
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wagner Cone Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	174

3. Primary Outcome

Title	Correct Reconstruction Aptafix
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aptafix Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	88

4. Secondary Outcome

Title	Combined Anteversion CLS
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CLS Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	153

5. Secondary Outcome

Title	Combined Anteversion Wagner Cone
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wagner Cone Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	197

6. Secondary Outcome

Title	Combined Anteversion Aptafix
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aptafix Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	121

7. Secondary Outcome

Title	Offset CLS
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CLS Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	192

8. Secondary Outcome

Title	Offset Wagner Cone
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wagner Cone Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	186

9. Secondary Outcome

Title	Offset Aptafix
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aptafix Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	164

10. Secondary Outcome

Title	Leg Lengthening CLS
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CLS Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	188

11. Secondary Outcome

Title	Leg Lengthening Wagner Cone
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wagner Cone Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	194

12. Secondary Outcome

Title	Leg Lengthening Aptafix
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aptafix Stem
Arm/Group Description	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.
Measure Participants	150
Measure Hips	200
Count of Units [Hips]	183

Adverse Events

Time Frame	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not assessed
Adverse Event Reporting Description	No adverse events were reported, results of the article are based on a prosthetic implants planning software performed on CT scan images.
Arm/Group Title	CLS Stem		Wagner Cone Stem		Aptafix Stem
Arm/Group Description	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.		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.		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.
All Cause Mortality
	CLS Stem		Wagner Cone Stem		Aptafix Stem
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	CLS Stem		Wagner Cone Stem		Aptafix Stem
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	CLS Stem		Wagner Cone Stem		Aptafix Stem
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.