Degenerative Hip Joint DiseaseOR3ONCT04941729
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System
A study testing OR3O™ - Dual Mobility System and Conventional in people with Degenerative Hip Joint Disease and Rheumatoid Arthritis (RA), run by Smith & Nephew Medical (Shanghai) Ltd at 4 sites in China.
Trial summary
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures
- What is being tested?
- OR3O™ - Dual Mobility System and Conventional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesChina
- Study dates
- 24 Jun 2022to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System or single-bearing design Total Hip System in primary total hip replacement in the Investigator's judgement.
- Subject is skeletally mature in the Investigator's judgement.
- Subject is 18 - 80 years old (inclusive).
- Subject is receiving total hip replacement for the first time on the affected hip.
- Subject has any of the following conditions:
- Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis(RA);
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- Fracture or avascular necrosis of the femoral head;
- All forms of osteoarthritis(OA);
- Patients with hips at risk of dislocation;
- Femoral neck fracture or proximal hip joint fracture.
- Subject provides written informed consent for study participation using an Ethical Committee (EC) approved consent form before any study procedures are performed, including pre-operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
- Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
- Subjects with preoperative HHS ≤ 79 (fair or worse category).
Who cannot join
- Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
- blood supply limitations;
- insufficient quantity or quality of bone support, e.g., osteoporosis, metabolic disorders which may impair bone formation, radioactive bone disease, tumor around hip joint, and osteomalacia;
- infections or other conditions which may lead to increased bone resorption.
- Subject has dysplasia of hip joint with CROWE Grade III, IV.
- Subject has weak constitution or failing to endure the surgery due to other diseases of the body.
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- Subject has bodily disease(s) that may interfere with THA survival or outcome.
- Subject has life expectancy of less than 2 years.
- Subject has mental or neurological conditions which impair the subject's ability or willingness to restrict activities that may put the affected limb at risk.
- Subject has physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities.
- Subject has neuromuscular dysfunctions (paralysis, myolysis and abductor muscle weakness) which will cause unstable hip joint or abnormal gait after surgery.
- Subject has a mental or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
- Subject has an active infection - systemic or at the site of intended surgery.
- Subject has a Body Mass Index ≥ 40.0 kg/m².
- Subject has a known allergy to any component of the devices used in the study.
- Subject is pregnant or breast feeding.
- Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation.
- Subjects that are expected with poor compliance.
- Subjects with complications of other diseases are limited to participate in the research, not able to comply with the follow-up or have impact on scientific integrity.
- Subjects with preoperative HHS ≥ 80 (good to excellent category).
- Subject has other diseases or conditions that investigator considers not appropriate to participate in the study.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University Third Hospital
Beijing, 100191
The Ninth People's Hospital affiliated to Shanghai Jiao Tong University Medical College
Shanghai, 200011
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, 830054
About this study
Official title: A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System Versus Conventional Single Bearing Design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures.
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in China as well as to support and maintain product registration in global markets.
Primary Objective: Assess safety and efficacy of the OR3O™ Dual Mobility System in Primary THA at 1 year postoperative.
Read more
Secondary Objective(s): Assess safety and efficacy of the OR3O™ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery.
Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation.
4 study sites in China.
- Conditions
- Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures, Avascular Necrosis of Femoral Head, Osteoarthritis (OA), Hip Dislocation
- Being tested
- OR3O™ - Dual Mobility System, Conventional
- Keywords
- Total Hip Arthroplasty (THA)
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Rheumatoid, Femoral Neck Fractures, Femur Head Necrosis, Osteoarthritis, Hip Dislocation, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OR3O™ - Dual Mobility SystemDevice
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).
ConventionalDevice
A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm (dual mobility) | Experimental | OR3O™ Dual Mobility in subjects who undergo Primary THA. Receives: Device: OR3O™ - Dual Mobility System |
| Controlled Arm (conventional) | Active comparator | A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Receives: Device: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months
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).
Measured: 12 months
Secondary outcomes (13)
Survivorship of the OR3O™ Dual Mobility System
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.
Measured: 6 weeks, 3 months, 6 months, and 12 months
Harris Hip Score (HHS)
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).
Measured: Preoperative, 6 weeks, 6 months, and 12 months
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score
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).
Measured: Preoperative, 6 weeks, 6 months, and 12 months
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score
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.
Measured: Preoperative, 6 weeks, 6 months, and 12 months
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)
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).
Measured: Preoperative, 6 weeks, 6 months, and 12 months
Radiographic Assessment - Implant Position/Orientation
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
Measured: 6 months and 12 months
Radiographic Assessment - Implant Subsidence/Migration
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
Measured: 6 months and 12 months
Radiographic Assessment - Heterotopic Ossification
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)
Measured: 6 months and 12 months
Radiographic Assessment - Radiolucencies
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'.
Measured: 6 months and 12 months
Radiographic Assessment - Osteolysis
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).
Measured: 6 months and 12 months
Radiographic Assessment - Implant Loosening
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
Measured: 6 months and 12 months
Radiographic Assessment - Stress Shielding
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
Measured: 6 months and 12 months
Radiographic Assessment - Periprosthetic Fractures
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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start24 Jun 2022
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Why it stopped: Change on clinical and marketing strategy for the devices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative Hip Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Medical (Shanghai) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Cao, Principal investigator, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941729
- Sponsor's protocol ID
- OR3O.2019.10 (CHINA)
- Acronym
- OR3O
- Status last verified
- Nov 2024
- First submitted
- 13 May 2021
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System Versus Conventional Single Bearing Design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures.
- ClinicalTrials.gov ID
- NCT04941729
- Acronym / sponsor ID
- OR3O / OR3O.2019.10 (CHINA)
- Conditions
- Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures, Avascular Necrosis of Femoral Head, Osteoarthritis (OA), Hip Dislocation
- Keywords
- Total Hip Arthroplasty (THA)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change on clinical and marketing strategy for the devices
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Smith & Nephew Medical (Shanghai) LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in China as well as to support and maintain product registration in global markets.
Primary Objective: Assess safety and efficacy of the OR3O™ Dual Mobility System in Primary THA at 1 year postoperative.
Secondary Objective(s): Assess safety and efficacy of the OR3O™ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery.
Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation.
4 study sites in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm (dual mobility) | Experimental | Device: OR3O™ - Dual Mobility SystemOR3O™ Dual Mobility in subjects who undergo Primary THA. |
| Controlled Arm (conventional) | Active comparator | Device: ConventionalA conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System or single-bearing design Total Hip System in primary total hip replacement in the Investigator's judgement.
- Subject is skeletally mature in the Investigator's judgement.
- Subject is 18 - 80 years old (inclusive).
- Subject is receiving total hip replacement for the first time on the affected hip.
- Subject has any of the following conditions:
Key exclusion criteria (21 listed)
- Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
- Subject has dysplasia of hip joint with CROWE Grade III, IV.
- Subject has weak constitution or failing to endure the surgery due to other diseases of the body.
- Subject has bodily disease(s) that may interfere with THA survival or outcome.
- Subject has life expectancy of less than 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OR3O™ - Dual Mobility SystemOR3O™ 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). | Device | Study Arm (dual mobility) |
| ConventionalA conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head. | Device | Controlled Arm (conventional) |
Primary outcome
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months
Time frame: 12 months
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).
13 secondary outcomes
Survivorship of the OR3O™ Dual Mobility System
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Harris Hip Score (HHS)
Time frame: Preoperative, 6 weeks, 6 months, and 12 months
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score
Time frame: Preoperative, 6 weeks, 6 months, and 12 months
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score
Time frame: Preoperative, 6 weeks, 6 months, and 12 months
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)
Time frame: Preoperative, 6 weeks, 6 months, and 12 months
Radiographic Assessment - Implant Position/Orientation
Time frame: 6 months and 12 months
Radiographic Assessment - Implant Subsidence/Migration
Time frame: 6 months and 12 months
Radiographic Assessment - Heterotopic Ossification
Time frame: 6 months and 12 months
Radiographic Assessment - Radiolucencies
Time frame: 6 months and 12 months
Radiographic Assessment - Osteolysis
Time frame: 6 months and 12 months
Radiographic Assessment - Implant Loosening
Time frame: 6 months and 12 months
Radiographic Assessment - Stress Shielding
Time frame: 6 months and 12 months
Radiographic Assessment - Periprosthetic Fractures
Time frame: 6 months and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Cao principal investigator
First Affiliated Hospital of Xinjiang Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OR3O™ - Dual Mobility System and Conventional in people with Degenerative Hip Joint Disease and Rheumatoid Arthritis (RA), run by Smith & Nephew Medical (Shanghai) Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.