Trial Outcomes & Findings for Pinnacle RSA Study (NCT NCT04070989)

Last Updated: 2025-12-19

Results Overview

RSA measured mean superior cup migration (subsidence: Y translation in mm) at 6 week and 2 years for each surgical approach separately, as well as combined

Recruitment status

TERMINATED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

At 6 week and 2 years

Results posted on

2025-12-19

Participant Flow

Out of total 100 participants enrolled, 84 participants underwent surgery via either posterior, lateral, or anterior approach. The remaining 16 participants were either withdrawn prior to surgery or the study was terminated prior to surgery and thus they were not included in a surgical approach group.

Participant milestones

Participant milestones
Measure	Posterior Approach Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach.	Lateral Approach Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach.	Anterior Approach Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach.
Overall Study STARTED	40	20	24
Overall Study COMPLETED	29	10	0
Overall Study NOT COMPLETED	11	10	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Posterior Approach Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach.	Lateral Approach Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach.	Anterior Approach Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach.
Overall Study Death	1	0	0
Overall Study Study Terminated by Sponsor	7	8	23
Overall Study Withdrawal by Subject	0	1	0
Overall Study Inclusion/Exclusion Criteria not met	2	0	1
Overall Study Other	1	1	0

Baseline Characteristics

Safety Analysis Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Posterior Approach n=40 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=20 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=24 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Total n=84 Participants Total of all reporting groups
Age, Continuous	69.53 years STANDARD_DEVIATION 8.85 • n=40 Participants	65.0 years STANDARD_DEVIATION 9.39 • n=20 Participants	60.5 years STANDARD_DEVIATION 12.72 • n=24 Participants	65.87 years STANDARD_DEVIATION 10.81 • n=84 Participants
Sex: Female, Male Female	20 Participants n=40 Participants • Safety Analysis Set	11 Participants n=20 Participants • Safety Analysis Set	9 Participants n=24 Participants • Safety Analysis Set	40 Participants n=84 Participants • Safety Analysis Set
Sex: Female, Male Male	20 Participants n=40 Participants • Safety Analysis Set	9 Participants n=20 Participants • Safety Analysis Set	15 Participants n=24 Participants • Safety Analysis Set	44 Participants n=84 Participants • Safety Analysis Set
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Primary Diagnosis Osteoarthritis	5 Participants n=40 Participants • Safety Analysis Set	6 Participants n=20 Participants • Safety Analysis Set	23 Participants n=24 Participants • Safety Analysis Set	34 Participants n=84 Participants • Safety Analysis Set
Primary Diagnosis Avascular necrosis	1 Participants n=40 Participants • Safety Analysis Set	0 Participants n=20 Participants • Safety Analysis Set	1 Participants n=24 Participants • Safety Analysis Set	2 Participants n=84 Participants • Safety Analysis Set
Primary Diagnosis Degenerative Joint Disease	34 Participants n=40 Participants • Safety Analysis Set	14 Participants n=20 Participants • Safety Analysis Set	0 Participants n=24 Participants • Safety Analysis Set	48 Participants n=84 Participants • Safety Analysis Set
BMI	31.19 kg/m2 STANDARD_DEVIATION 6.73 • n=40 Participants • Safety Analysis Set	30.36 kg/m2 STANDARD_DEVIATION 6.75 • n=20 Participants • Safety Analysis Set	30.32 kg/m2 STANDARD_DEVIATION 5.43 • n=24 Participants • Safety Analysis Set	30.74 kg/m2 STANDARD_DEVIATION 6.33 • n=84 Participants • Safety Analysis Set

PRIMARY outcome

Timeframe: At 6 week and 2 years

Population: Per Protocol Analysis Set

RSA measured mean superior cup migration (subsidence: Y translation in mm) at 6 week and 2 years for each surgical approach separately, as well as combined

Outcome measures

Outcome measures
Measure	Posterior Approach n=27 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=15 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=22 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Overall Population n=64 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach.
Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years RSA Measured Subsidence (Y-axis Translation) at 6 weeks	-0.001 mm Standard Deviation 0.065	-0.03 mm Standard Deviation 0.094	-0.036 mm Standard Deviation 0.133	-0.02 mm Standard Deviation 0.099
Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years RSA Measured Subsidence (Y-axis Translation) at 2yrs	0.06 mm Standard Deviation 0.292	0.045 mm Standard Deviation 0.501	—	0.055 mm Standard Deviation 0.362

PRIMARY outcome

Timeframe: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years

Population: Per Protocol Analysis Set. Here 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure while 'n' (number analyzed) signifies participants evaluable for each timepoint. n=0 signifies no participant was available for the analysis.

Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty. It assesses patient pain (2 items), and functions of daily living (4 items). Response to each item is scored from 0 (none) to 4 (extreme). Raw scores are added up and then converted to an interval score (0-100) using an interval table. The final interval score represents a patients total joint disability where 0 corresponds to total joint disability (worse outcome) and 100 is perfect joint health (best outcome).

Outcome measures

Outcome measures
Measure	Posterior Approach n=27 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=15 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=22 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Overall Population Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach.
Patient Reported Outcome Measures (PROMs)- HOOS Jr. HOOS Jr. at Pre-op	52.61 Units on a scale Standard Deviation 11.92	54.47 Units on a scale Standard Deviation 13.99	52.88 Units on a scale Standard Deviation 16.63	—
Patient Reported Outcome Measures (PROMs)- HOOS Jr. HOOS Jr. at 6 weeks follow-up	78.99 Units on a scale Standard Deviation 11.68	80.22 Units on a scale Standard Deviation 14.96	75.78 Units on a scale Standard Deviation 12.22	—
Patient Reported Outcome Measures (PROMs)- HOOS Jr. HOOS Jr. at 3 months follow-up	83.17 Units on a scale Standard Deviation 14.02	88.37 Units on a scale Standard Deviation 13.91	89.07 Units on a scale Standard Deviation 12.62	—
Patient Reported Outcome Measures (PROMs)- HOOS Jr. HOOS Jr. at 6 months follow-up	85.7 Units on a scale Standard Deviation 14.98	90.64 Units on a scale Standard Deviation 14.19	89.89 Units on a scale Standard Deviation 12.00	—
Patient Reported Outcome Measures (PROMs)- HOOS Jr. HOOS Jr. at 1 year follow-up	92.71 Units on a scale Standard Deviation 11.22	91.7 Units on a scale Standard Deviation 15.27	97.54 Units on a scale Standard Deviation 6.02	—
Patient Reported Outcome Measures (PROMs)- HOOS Jr. HOOS Jr. at 2 years follow-up	89.76 Units on a scale Standard Deviation 15.98	94.5 Units on a scale Standard Deviation 7.42	—	—

PRIMARY outcome

Timeframe: At 6 weeks, 3 months, 6 months, 1 year and 2 years

The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions with response ranging from 0 (never) to 4 (mostly). All responses are summed and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of "forgetting" the artificial joint, that is, a low degree of awareness.

Outcome measures

Outcome measures
Measure	Posterior Approach n=27 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=13 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=22 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Overall Population Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach.
Patient Reported Outcome Measures (PROMs)- FJS-12 FJS-12 Score at 6 weeks follow-up	54.74 Units on a scale Standard Deviation 26.14	48.14 Units on a scale Standard Deviation 29.7	55.88 Units on a scale Standard Deviation 28.93	—
Patient Reported Outcome Measures (PROMs)- FJS-12 FJS-12 Score at 3 months follow-up	63.35 Units on a scale Standard Deviation 26.5	70.27 Units on a scale Standard Deviation 31.71	69.26 Units on a scale Standard Deviation 29.48	—
Patient Reported Outcome Measures (PROMs)- FJS-12 FJS-12 Score at 6 months follow-up	67.33 Units on a scale Standard Deviation 29.78	81.88 Units on a scale Standard Deviation 18.94	82.64 Units on a scale Standard Deviation 20.06	—
Patient Reported Outcome Measures (PROMs)- FJS-12 FJS-12 Score at 1 year follow-up	82.06 Units on a scale Standard Deviation 22.58	75.87 Units on a scale Standard Deviation 27.91	91.95 Units on a scale Standard Deviation 10.79	—
Patient Reported Outcome Measures (PROMs)- FJS-12 FJS-12 Score at 2 years follow-up	82.67 Units on a scale Standard Deviation 23.72	84.72 Units on a scale Standard Deviation 11.02	—	—

SECONDARY outcome

Timeframe: At 3 months, 6 months and 1 year

Population: Per Protocol Analysis Set

Outcome measures

Outcome measures
Measure	Posterior Approach n=27 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=15 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=22 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Overall Population n=64 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach.
RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year RSA measured subsidence of the Pinnacle Acetabular Shell at 3 months f/up	0.044 mm Standard Deviation 0.11	-0.065 mm Standard Deviation 0.103	-0.062 mm Standard Deviation 0.272	-0.025 mm Standard Deviation 0.187
RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year RSA measured subsidence of the Pinnacle Acetabular Shell at 6 months f/up	0.13 mm Standard Deviation 0.314	0.047 mm Standard Deviation 0.320	-0.011 mm Standard Deviation 0.192	0.07 mm Standard Deviation 0.289
RSA Measured Subsidence of the Pinnacle Acetabular Shell at 3 Months, 6 Months and 1 Year RSA measured subsidence of the Pinnacle Acetabular Shell at 1 year f/up	0.065 mm Standard Deviation 0.232	0.05 mm Standard Deviation 0.377	-0.12 mm Standard Deviation 0.287	0.032 mm Standard Deviation 0.286

SECONDARY outcome

Timeframe: At 6 weeks, 3 months, 6 months, 1 year, 2 years

Population: Per Protocol Analysis Set

Other RSA measurements (X translations in mm) at all time points

Outcome measures

Outcome measures
Measure	Posterior Approach n=27 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=15 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=22 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Overall Population n=64 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach.
Other RSA Measurements (X-Translations) X-axis translations (mm) at 6 weeks	0.009 mm Standard Deviation 0.082	-0.016 mm Standard Deviation 0.214	0.049 mm Standard Deviation 0.119	0.017 mm Standard Deviation 0.134
Other RSA Measurements (X-Translations) X-axis translations (mm) at 3 months	-0.085 mm Standard Deviation 0.229	-0.042 mm Standard Deviation 0.277	0.028 mm Standard Deviation 0.321	-0.033 mm Standard Deviation 0.276
Other RSA Measurements (X-Translations) X-axis translations (mm) at 6 months	-0.001 mm Standard Deviation 0.271	-0.02 mm Standard Deviation 0.3	0.113 mm Standard Deviation 0.402	0.025 mm Standard Deviation 0.317
Other RSA Measurements (X-Translations) X-axis translations (mm) at 1 year	-0.029 mm Standard Deviation 0.284	0.06 mm Standard Deviation 0.283	0.146 mm Standard Deviation 0.261	0.022 mm Standard Deviation 0.282
Other RSA Measurements (X-Translations) X-axis translations (mm) at 2 years	-0.057 mm Standard Deviation 0.372	-0.026 mm Standard Deviation 0.361	—	-0.047 mm Standard Deviation 0.363

SECONDARY outcome

Timeframe: At 6 weeks, 3 months, 6 months, 1 year, 2 years

Population: Per Protocol Analysis Set

Other RSA measurements (Z translations in mm) at all time points

Outcome measures

Outcome measures
Measure	Posterior Approach n=27 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=15 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=22 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Overall Population n=64 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach.
Other RSA Measurements (Z-Translations) Z-axis translations (mm) at 6 weeks	-0.033 mm Standard Deviation 0.134	-0.06 mm Standard Deviation 0.15	-0.033 mm Standard Deviation 0.227	-0.039 mm Standard Deviation 0.172
Other RSA Measurements (Z-Translations) Z-axis translations (mm) at 3 months	-0.087 mm Standard Deviation 0.317	-0.095 mm Standard Deviation 0.379	0.127 mm Standard Deviation 0.409	-0.013 mm Standard Deviation 0.376
Other RSA Measurements (Z-Translations) Z-axis translations (mm) at 6 months	-0.023 mm Standard Deviation 0.303	-0.199 mm Standard Deviation 0.341	-0.004 mm Standard Deviation 0.759	-0.063 mm Standard Deviation 0.476
Other RSA Measurements (Z-Translations) Z-axis translations (mm) at 1 year	-0.112 mm Standard Deviation 0.234	0.014 mm Standard Deviation 0.41	-0.095 mm Standard Deviation 0.462	-0.076 mm Standard Deviation 0.325
Other RSA Measurements (Z-Translations) Z-axis translations (mm) at 2 years	-0.207 mm Standard Deviation 0.344	-0.061 mm Standard Deviation 0.466	—	-0.161 mm Standard Deviation 0.385

SECONDARY outcome

Timeframe: At 6 weeks, 3 months, 6 months, 1 year, 2 years

Population: Per Protocol Analysis Set

X, Y, and Z rotations in degrees at all time points

Outcome measures

Outcome measures
Measure	Posterior Approach n=27 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=15 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=22 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Overall Population n=64 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach.
Other RSA Measurements (Rotations) X-axis Rotation at 6 Weeks	0.023 Degrees Standard Deviation 0.368	-0.175 Degrees Standard Deviation 0.612	0.059 Degrees Standard Deviation 0.55	-0.009 Degrees Standard Deviation 0.495
Other RSA Measurements (Rotations) Y-axis Rotation at 6 weeks	0.035 Degrees Standard Deviation 0.472	0.357 Degrees Standard Deviation 0.588	-0.033 Degrees Standard Deviation 0.372	0.085 Degrees Standard Deviation 0.487
Other RSA Measurements (Rotations) Z-axis Rotation at 6 weeks	0.045 Degrees Standard Deviation 0.35	0.135 Degrees Standard Deviation 0.384	0.026 Degrees Standard Deviation 0.377	0.059 Degrees Standard Deviation 0.364
Other RSA Measurements (Rotations) X-axis Rotation at 3 months	-0.368 Degrees Standard Deviation 1.046	-0.021 Degrees Standard Deviation 1.311	-0.201 Degrees Standard Deviation 0.528	-0.209 Degrees Standard Deviation 0.974
Other RSA Measurements (Rotations) Y-axis Rotation at 3 months	0.027 Degrees Standard Deviation 0.966	0.053 Degrees Standard Deviation 1.715	0.054 Degrees Standard Deviation 0.56	0.044 Degrees Standard Deviation 1.102
Other RSA Measurements (Rotations) Z-axis Rotation at 3 months	-0.196 Degrees Standard Deviation 0.475	-0.231 Degrees Standard Deviation 0.71	0.343 Degrees Standard Deviation 1.113	-0.013 Degrees Standard Deviation 0.841
Other RSA Measurements (Rotations) X-axis Rotation at 6 months	-0.241 Degrees Standard Deviation 0.81	-0.34 Degrees Standard Deviation 0.811	0.481 Degrees Standard Deviation 3.181	-0.069 Degrees Standard Deviation 1.789
Other RSA Measurements (Rotations) Y-axis Rotation at 6 months	0.137 Degrees Standard Deviation 0.967	0.585 Degrees Standard Deviation 1.043	-0.254 Degrees Standard Deviation 1.693	0.145 Degrees Standard Deviation 1.238
Other RSA Measurements (Rotations) Z-axis Rotation at 6 months	0.062 Degrees Standard Deviation 0.591	0.069 Degrees Standard Deviation 0.575	0.549 Degrees Standard Deviation 1.68	0.196 Degrees Standard Deviation 1.01
Other RSA Measurements (Rotations) X-axis Rotation at 1 year	-0.024 Degrees Standard Deviation 0.575	0.343 Degrees Standard Deviation 1.467	-0.943 Degrees Standard Deviation 0.773	-0.069 Degrees Standard Deviation 0.988
Other RSA Measurements (Rotations) Y-axis Rotation at 1 year	0.043 Degrees Standard Deviation 0.494	-0.272 Degrees Standard Deviation 1.774	0.73 Degrees Standard Deviation 0.738	0.066 Degrees Standard Deviation 1.049
Other RSA Measurements (Rotations) Z-axis Rotation at 1 year	0.067 Degrees Standard Deviation 0.523	-0.033 Degrees Standard Deviation 0.636	-0.306 Degrees Standard Deviation 0.774	-0.018 Degrees Standard Deviation 0.596
Other RSA Measurements (Rotations) X-axis Rotation at 2 years	-0.223 Degrees Standard Deviation 0.703	0.26 Degrees Standard Deviation 1.392	—	-0.072 Degrees Standard Deviation 0.974
Other RSA Measurements (Rotations) Y-axis Rotation at 2 years	0.216 Degrees Standard Deviation 0.801	-0.156 Degrees Standard Deviation 1.406	—	0.1 Degrees Standard Deviation 1.019
Other RSA Measurements (Rotations) Z-axis Rotation at 2 years	0.284 Degrees Standard Deviation 0.714	-0.001 Degrees Standard Deviation 0.793	—	0.195 Degrees Standard Deviation 0.739

SECONDARY outcome

Timeframe: At 1 year and 2 years

Linear head penetration at 1 year and 2 years for each surgical approach separately was reported.

Outcome measures

Outcome measures
Measure	Posterior Approach n=27 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=12 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=7 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Overall Population Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach.
Linear Head Penetration Linear Head Penetration at 1 year f/up	0.182 mm Standard Deviation 0.107	0.211 mm Standard Deviation 0.09	0.286 mm Standard Deviation 0.086	—
Linear Head Penetration Linear Head Penetration at 2 years f/up	0.228 mm Standard Deviation 0.101	0.321 mm Standard Deviation 0.192	—	—

SECONDARY outcome

Timeframe: Pre Operation (-Day90 to Day 0), At 6 weeks, 3 months, 6 months, 1 year and 2 years

The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result.

Outcome measures

Outcome measures
Measure	Posterior Approach n=27 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=15 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=22 Participants Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach	Overall Population Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach, lateral approach and the anterior approach.
Patient Reported Outcome Measures (PROMs)- Harris Hip Score HHS at 3 months follow-up	90.08 Units on a scale Standard Deviation 10.51	89.00 Units on a scale Standard Deviation 15.58	93.18 Units on a scale Standard Deviation 6.11	—
Patient Reported Outcome Measures (PROMs)- Harris Hip Score HHS at Pre-op	57.6 Units on a scale Standard Deviation 15.14	49.47 Units on a scale Standard Deviation 20.16	61.23 Units on a scale Standard Deviation 12.61	—
Patient Reported Outcome Measures (PROMs)- Harris Hip Score HHS at 6 weeks follow-up	82.14 Units on a scale Standard Deviation 11.52	76.67 Units on a scale Standard Deviation 15.91	86.00 Units on a scale Standard Deviation 14.07	—
Patient Reported Outcome Measures (PROMs)- Harris Hip Score HHS at 6 months follow-up	91.09 Units on a scale Standard Deviation 11.22	93.89 Units on a scale Standard Deviation 9.51	96.71 Units on a scale Standard Deviation 5.50	—
Patient Reported Outcome Measures (PROMs)- Harris Hip Score HHS at 1 year follow-up	94.93 Units on a scale Standard Deviation 7.95	96.27 Units on a scale Standard Deviation 6.48	100 Units on a scale Standard Deviation 0	—
Patient Reported Outcome Measures (PROMs)- Harris Hip Score HHS at 2 years follow-up	93.27 Units on a scale Standard Deviation 12.55	95.44 Units on a scale Standard Deviation 7.99	—	—

Adverse Events

Posterior Approach

Serious events: 8 serious events

Other events: 9 other events

Deaths: 1 deaths

Lateral Approach

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Anterior Approach

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Posterior Approach n=40 participants at risk Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=20 participants at risk Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=24 participants at risk Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach
Musculoskeletal and connective tissue disorders Osteoarthritis	12.5% 5/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	10.0% 2/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Gastrointestinal disorders Duodenal ulcer	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Gastrointestinal disorders Gastrointestinal ulcer	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Infections and infestations Corona virus infection	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Infections and infestations Influenza	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Cardiac disorders Atrioventricular block complete	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Eye disorders Cataract	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenocortical carcinoma	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Nervous system disorders Brain injury	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.

Other adverse events

Additional Information

Mary Panozzo

JnJ MedTech

Phone: +15744049398

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Posterior Approach n=40 participants at risk Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach	Lateral Approach n=20 participants at risk Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach	Anterior Approach n=24 participants at risk Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach
Injury, poisoning and procedural complications Iliotibial band syndrome	5.0% 2/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Injury, poisoning and procedural complications Incision site discharge	5.0% 2/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Injury, poisoning and procedural complications Acetabulum fracture	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Injury, poisoning and procedural complications Femur fracture	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Injury, poisoning and procedural complications Incision site erythema	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	5.0% 1/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 2/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Nervous system disorders Hypoaesthesia	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	5.0% 1/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Musculoskeletal and connective tissue disorders Limb asymmetry	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Blood and lymphatic system disorders Anaemia	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Nervous system disorders Syncope	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Vascular disorders Deep vein thrombosis	2.5% 1/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Vascular disorders Hypotension	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	5.0% 1/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	5.0% 1/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	5.0% 1/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Infections and infestations Stitch abscess	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	10.0% 2/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Infections and infestations Cellulitis	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	5.0% 1/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
Cardiac disorders Bradycardia	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.
General disorders Hypothermia	0.00% 0/40 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	0.00% 0/20 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.	4.2% 1/24 • Day 0 up to 2 years Safety analysis set included all enrolled participants who received THA surgery. Participants were analyzed according to the surgical approach applied during the study.