Trial Outcomes & Findings for Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software (NCT NCT04904640)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

150 participants

Primary outcome timeframe

Day 0

Results posted on

2021-09-09

Participant Flow

Random selection of pre-operative Ct including native dysplastic hips

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.

Unit of analysis: Hips

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	150 200
Overall Study COMPLETED	150 200
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simulated Hips n=200 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)
Age, Continuous	50.8 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	115 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	150 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	150 hips n=5 Participants • 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.
height	159.8 centimeters STANDARD_DEVIATION 18.3 • n=5 Participants
weight	66.1 kg STANDARD_DEVIATION 15.3 • n=5 Participants
BMI	25.8 kg/m² STANDARD_DEVIATION 4.9 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Correct Reconstruction CLS	138 Hips

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Correct Reconstruction Wagner Cone	174 Hips

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Correct Reconstruction Aptafix	88 Hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Combined Anteversion CLS	153 Hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Combined Anteversion Wagner Cone	197 Hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Combined Anteversion Aptafix	121 Hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Offset CLS	192 Hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Offset Wagner Cone	186 Hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Offset Aptafix	164 Hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Leg Lengthening CLS	188 Hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Leg Lengthening Wagner Cone	194 Hips

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	CLS Stem n=200 Hips 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.
Leg Lengthening Aptafix	183 Hips

Adverse Events

CLS Stem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wagner Cone Stem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aptafix Stem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Francesco Castagnini, MD

IRCCS Istituto Ortopedico Rizzoli

Phone: +390516366418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place