Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System (NCT NCT04941729)

NCT ID: NCT04941729

Last Updated: 2025-05-21

Results Overview

Number of participants with an excellent (≥ 90) or good (80-89) Harris Hip Score at 12 months postoperative (No/Yes). The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-05-21

Participant Flow

A total of 24 participants were consented. Two participants were excluded from the study prior to receiving study treatment due to screen failure and withdrawal by the participant.

Participant milestones

Measure	Study Arm (Dual Mobility) OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Overall Study STARTED	11	11
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	11	11

Reasons for withdrawal

Measure	Study Arm (Dual Mobility) OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Overall Study Death	0	1
Overall Study Study terminated by sponsor	11	10

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System

Baseline characteristics by cohort

Measure	Study Arm (Dual Mobility) n=11 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=11 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.	Total n=22 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 10.5 • n=5 Participants	65.1 years STANDARD_DEVIATION 9.6 • n=7 Participants	60.8 years STANDARD_DEVIATION 10.8 • n=5 Participants
Age, Customized Age Category · < 60 years	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Age, Customized Age Category · ≥ 60 years	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Race · Chinese	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Race · Han	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Body Mass Index (BMI)	25.2 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants	23.5 kg/m^2 STANDARD_DEVIATION 3.7 • n=7 Participants	24.4 kg/m^2 STANDARD_DEVIATION 3.6 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified.

Number of participants with an excellent (≥ 90) or good (80-89) Harris Hip Score at 12 months postoperative (No/Yes).

The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).

Outcome measures

Measure	Study Arm (Dual Mobility) n=7 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=7 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months No	1 Participants	4 Participants
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months Yes	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 6 weeks, 3 months, 6 months, and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.

Survivorship of the OR3O™ Dual Mobility System measured by Kaplan-Meier survival estimate. Survivorship was defined as number of hips with no revision due to any reason.

Outcome measures

Measure	Study Arm (Dual Mobility) n=11 hips OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=11 hips A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Survivorship of the OR3O™ Dual Mobility System 6 weeks	11 hips	11 hips
Survivorship of the OR3O™ Dual Mobility System 3 months	10 hips	10 hips
Survivorship of the OR3O™ Dual Mobility System 6 months	10 hips	9 hips
Survivorship of the OR3O™ Dual Mobility System 12 months	5 hips	5 hips

SECONDARY outcome

Timeframe: Preoperative, 6 weeks, 6 months, and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.

The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores range from 0 (worst) to 100 (best).

Outcome measures

Measure	Study Arm (Dual Mobility) n=11 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=11 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Harris Hip Score (HHS) Preoperative	34.09 score on a scale Standard Deviation 22.42	31.55 score on a scale Standard Deviation 19.44
Harris Hip Score (HHS) 6 weeks	71 score on a scale Standard Deviation NA Standard Deviation could not be calculated because data was only collected for one participant	51 score on a scale Standard Deviation NA Standard Deviation could not be calculated because data was only collected for one participant
Harris Hip Score (HHS) 6 months	73.1 score on a scale Standard Deviation 7.45	72.33 score on a scale Standard Deviation 6.78
Harris Hip Score (HHS) 12 months	81.86 score on a scale Standard Deviation 4.74	75.71 score on a scale Standard Deviation 8.65

SECONDARY outcome

Timeframe: Preoperative, 6 weeks, 6 months, and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.

The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The EQ VAS score is on a scale of 0 to 100 with 0 indicating 'the worst health you can imagine' and 100 indicating 'the best health you can imagine' (i.e., a higher score is a better outcome).

Outcome measures

Measure	Study Arm (Dual Mobility) n=11 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=11 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score Preoperative	51.82 score on a scale Standard Deviation 27.14	55.91 score on a scale Standard Deviation 17.44
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score 6 weeks	72.5 score on a scale Standard Deviation 3.54	80 score on a scale Standard Deviation NA Standard Deviation could not be calculated because data was only collected for one participant
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score 6 months	78 score on a scale Standard Deviation 11.35	76.67 score on a scale Standard Deviation 9.68
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score 12 months	81.43 score on a scale Standard Deviation 9.00	79.29 score on a scale Standard Deviation 8.86

SECONDARY outcome

Timeframe: Preoperative, 6 weeks, 6 months, and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.

The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) to create a combined Health Score. The combined Health Score is on a scale of 0 to 1 with a higher score indicating a better outcome.

Outcome measures

Measure	Study Arm (Dual Mobility) n=11 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=11 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score Preoperative	0.36 score on a scale Standard Deviation 0.30	0.37 score on a scale Standard Deviation 0.25
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score 6 weeks	0.63 score on a scale Standard Deviation 0.02	0.69 score on a scale Standard Deviation NA Standard Deviation could not be calculated because data was only collected for one participant
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score 6 months	0.74 score on a scale Standard Deviation 0.11	0.71 score on a scale Standard Deviation 0.14
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score 12 months	0.79 score on a scale Standard Deviation 0.11	0.73 score on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: Preoperative, 6 weeks, 6 months, and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.

The HOOS JR. is a short-form survey based on the Hip Disability and Osteoarthritis Outcome Score (HOOS) that specifically focuses on the outcome after Total Hip Arthroplasty (THA). HOOS JR. accesses pain and joint awareness during the activities of daily living. The scores range from 0 to 100 with 0 indicating total hip disability (i.e., the worst outcome) and 100 indicating perfect hip health (i.e., the best outcome).

Outcome measures

Measure	Study Arm (Dual Mobility) n=11 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=11 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) Preoperative	54.29 score on a scale Standard Deviation 23.57	46.69 score on a scale Standard Deviation 18.37
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) 6 weeks	64.68 score on a scale Standard Deviation 8.13	67.52 score on a scale Standard Deviation NA Standard Deviation could not be calculated because data was only collected for one participant
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) 6 months	80.42 score on a scale Standard Deviation 8.88	79.25 score on a scale Standard Deviation 15.29
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) 12 months	83.83 score on a scale Standard Deviation 10.14	74.91 score on a scale Standard Deviation 15.12

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.

Implant position/orientation determined by acetabular cup position from radiographs performed with the participant in a supine position. Participant implant position was categorized as one of the following:

• Unchanged
• Varus tilted
• Valgus tilted
• Subsidence

Outcome measures

Measure	Study Arm (Dual Mobility) n=7 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=7 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Radiographic Assessment - Implant Position/Orientation 12 months · Varus tilted	0 Participants	0 Participants
Radiographic Assessment - Implant Position/Orientation 12 months · Valgus tilted	0 Participants	0 Participants
Radiographic Assessment - Implant Position/Orientation 12 months · Subsidence	0 Participants	0 Participants
Radiographic Assessment - Implant Position/Orientation 6 months · Unchanged	4 Participants	3 Participants
Radiographic Assessment - Implant Position/Orientation 6 months · Varus tilted	0 Participants	0 Participants
Radiographic Assessment - Implant Position/Orientation 6 months · Valgus tilted	0 Participants	0 Participants
Radiographic Assessment - Implant Position/Orientation 6 months · Subsidence	0 Participants	0 Participants
Radiographic Assessment - Implant Position/Orientation 12 months · Unchanged	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.

Acetabular Cup Migration was determined based on cup fixation from radiographs with the subject in a supine position. Participant implant subsidence/migration was categorized as one of the following:

• Unchanged
• Migration cranial
• Migration medial
• Tilted

Outcome measures

Measure	Study Arm (Dual Mobility) n=7 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=7 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Radiographic Assessment - Implant Subsidence/Migration 6 months · Unchanged	4 Participants	3 Participants
Radiographic Assessment - Implant Subsidence/Migration 6 months · Migration cranial	0 Participants	0 Participants
Radiographic Assessment - Implant Subsidence/Migration 6 months · Migation medial	0 Participants	0 Participants
Radiographic Assessment - Implant Subsidence/Migration 6 months · Tilted	0 Participants	0 Participants
Radiographic Assessment - Implant Subsidence/Migration 12 months · Unchanged	7 Participants	7 Participants
Radiographic Assessment - Implant Subsidence/Migration 12 months · Migration cranial	0 Participants	0 Participants
Radiographic Assessment - Implant Subsidence/Migration 12 months · Migation medial	0 Participants	0 Participants
Radiographic Assessment - Implant Subsidence/Migration 12 months · Tilted	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.

Heterotopic Ossification determined from radiographs performed with the subject in a supine position using Brooker Classification. Heterotopic ossification for the participant was classified as one of following:

• Grade 0 (None, no islands of bone)
• Grade I (Islands of bone within the soft tissues about the hip)
• Grade II (Bone spurs from the pelvis or proximal end of the femur, leaving at least 1 cm between opposing bone surfaces)
• Grade III (Bone spurs from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm)
• Grade IV (Apparent bone ankylosis of the hip)

Outcome measures

Measure	Study Arm (Dual Mobility) n=7 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=7 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Radiographic Assessment - Heterotopic Ossification 6 months · Grade 0	4 Participants	3 Participants
Radiographic Assessment - Heterotopic Ossification 6 months · Grade IV	0 Participants	0 Participants
Radiographic Assessment - Heterotopic Ossification 12 months · Grade 0	7 Participants	7 Participants
Radiographic Assessment - Heterotopic Ossification 6 months · Grade I	0 Participants	0 Participants
Radiographic Assessment - Heterotopic Ossification 6 months · Grade II	0 Participants	0 Participants
Radiographic Assessment - Heterotopic Ossification 6 months · Grade III	0 Participants	0 Participants
Radiographic Assessment - Heterotopic Ossification 12 months · Grade I	0 Participants	0 Participants
Radiographic Assessment - Heterotopic Ossification 12 months · Grade II	0 Participants	0 Participants
Radiographic Assessment - Heterotopic Ossification 12 months · Grade III	0 Participants	0 Participants
Radiographic Assessment - Heterotopic Ossification 12 months · Grade IV	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.

Radiolucencies in the Acetabular Cup are defined as the presence of a linear gap or "halo" along the acetabular bone-implant interface identified from radiographs performed with the subject in a supine position. The presence of radiolucent lines for participants in any cup zones were categorized as either 'Yes' or 'No'.

Outcome measures

Measure	Study Arm (Dual Mobility) n=7 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=7 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Radiographic Assessment - Radiolucencies 6 months · Yes	0 Participants	0 Participants
Radiographic Assessment - Radiolucencies 6 months · No	4 Participants	3 Participants
Radiographic Assessment - Radiolucencies 12 months · Yes	0 Participants	0 Participants
Radiographic Assessment - Radiolucencies 12 months · No	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.

Osteolysis was determined from radiographs performed with the subject in a supine position. The presence of osteolysis in any cup zones for the participant identified as 'Yes' or 'No'. Presence of osteolysis indicated a ballooning / scalloping, progressive, periacetabular, bony destructive lesion with a maximum dimension > 5 millimeters (mm).

Outcome measures

Measure	Study Arm (Dual Mobility) n=7 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=7 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Radiographic Assessment - Osteolysis 6 months · Yes	0 Participants	0 Participants
Radiographic Assessment - Osteolysis 6 months · No	4 Participants	3 Participants
Radiographic Assessment - Osteolysis 12 months · Yes	0 Participants	0 Participants
Radiographic Assessment - Osteolysis 12 months · No	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.

Implant loosening was determined from radiographs performed with the subject in a supine position. The presence of loosening indicated apparent imaging features of loosening at the acetabular bone-implant interface including significant radiolucency or change in position of the acetabular cup indicating a loss of fixation. Implant loosening based on stem fixation for cemented stems for the participant was categorized as one of the following:

• Not applicable
• No loosening
• Possible loosening
• Probable loosening
• Definite loosening

Outcome measures

Measure	Study Arm (Dual Mobility) n=7 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=7 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Radiographic Assessment - Implant Loosening 6 months · Not applicable	0 Participants	0 Participants
Radiographic Assessment - Implant Loosening 6 months · No loosening	4 Participants	3 Participants
Radiographic Assessment - Implant Loosening 6 months · Possible loosening	0 Participants	0 Participants
Radiographic Assessment - Implant Loosening 6 months · Probable loosening	0 Participants	0 Participants
Radiographic Assessment - Implant Loosening 6 months · Definite loosening	0 Participants	0 Participants
Radiographic Assessment - Implant Loosening 12 months · Not applicable	0 Participants	0 Participants
Radiographic Assessment - Implant Loosening 12 months · No loosening	7 Participants	7 Participants
Radiographic Assessment - Implant Loosening 12 months · Possible loosening	0 Participants	0 Participants
Radiographic Assessment - Implant Loosening 12 months · Probable loosening	0 Participants	0 Participants
Radiographic Assessment - Implant Loosening 12 months · Definite loosening	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.

Image review by investigator of radiographs performed with the subject in a supine position to identify presence of medial stress shielding. Stress shielding for the participant based on the presence (Yes/No) of the following:

• Atrophy in any Cup Zones
• Atrophy in any Stem Zones

Outcome measures

Measure	Study Arm (Dual Mobility) n=7 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=7 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Radiographic Assessment - Stress Shielding 6 months: Atrophy in any Cup Zones · Yes	0 Participants	0 Participants
Radiographic Assessment - Stress Shielding 6 months: Atrophy in any Cup Zones · No	4 Participants	3 Participants
Radiographic Assessment - Stress Shielding 6 months: Atrophy in any Stem Zones · Yes	0 Participants	0 Participants
Radiographic Assessment - Stress Shielding 6 months: Atrophy in any Stem Zones · No	4 Participants	3 Participants
Radiographic Assessment - Stress Shielding 12 months: Atrophy in any Cup Zones · Yes	0 Participants	0 Participants
Radiographic Assessment - Stress Shielding 12 months: Atrophy in any Cup Zones · No	7 Participants	7 Participants
Radiographic Assessment - Stress Shielding 12 months: Atrophy in any Stem Zones · Yes	0 Participants	0 Participants
Radiographic Assessment - Stress Shielding 12 months: Atrophy in any Stem Zones · No	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.

Image review by investigator to identify presence of periprosthetic fractures (yes/no). An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs performed with the subject in a supine position.

Outcome measures

Measure	Study Arm (Dual Mobility) n=7 Participants OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=7 Participants A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Radiographic Assessment - Periprosthetic Fractures 6 months · Yes	0 Participants	0 Participants
Radiographic Assessment - Periprosthetic Fractures 6 months · No	4 Participants	3 Participants
Radiographic Assessment - Periprosthetic Fractures 12 months · Yes	0 Participants	0 Participants
Radiographic Assessment - Periprosthetic Fractures 12 months · No	7 Participants	7 Participants

Adverse Events

Study Arm (Dual Mobility)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Controlled Arm (Conventional)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Study Arm (Dual Mobility) n=11 participants at risk OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=11 participants at risk A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Skin and subcutaneous tissue disorders RIGHTBUTTOCKBOIL	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	0.00% 0/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)
Blood and lymphatic system disorders HYPOALBUMINEMIA	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	0.00% 0/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)
Renal and urinary disorders HYDRONEPHROSIS WITH URETERAL STONES	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	0.00% 0/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)
Blood and lymphatic system disorders HYPOHEMOGLOBIN	0.00% 0/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)
Respiratory, thoracic and mediastinal disorders RESPIRATORY BLEEDING	0.00% 0/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)
Eye disorders BLURRED VISION IN THE LEFT EYE WITH DEFORMATION OF VISION FOR OVER SIX MONTHS	0.00% 0/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)

Other adverse events

Measure	Study Arm (Dual Mobility) n=11 participants at risk OR3O™ Dual Mobility in subjects who undergo Primary THA. OR3O™ - Dual Mobility System: OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).	Controlled Arm (Conventional) n=11 participants at risk A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
Infections and infestations COVID-19 IS POSITIVE	18.2% 2/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	18.2% 2/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)
Vascular disorders LEFT CALF INTERMUSCULAR VEIN THROMBOSIS	0.00% 0/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)
Endocrine disorders HYPOKALEMIA	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	18.2% 2/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)
Blood and lymphatic system disorders HYPOALBUMINEMIA	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)	9.1% 1/11 • Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)

Additional Information

Senior Manager Clinical Compliance

Smith+Nephew, Inc

Phone: +44 7811 407089

Email: datasharing.gcs@smith-nephew.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60