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

Not Applicable

Terminated

Conditions: Femoral Neck Fractures
Hip Dislocation
Degenerative Hip Joint Disease
Rheumatoid Arthritis (RA)
Avascular Necrosis of Femoral Head
Osteoarthritis (OA)
Hip Fractures

Interventions: Device: Conventional
Device: OR3O™ - Dual Mobility System

Registration Number: NCT04941729

Lead Sponsor: Smith & Nephew Medical (Shanghai) Ltd

Brief 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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 24

Inclusion Criteria

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);
- 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).

Exclusion Criteria

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.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controlled Arm (conventional)	Conventional	A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA.
Study Arm (dual mobility)	OR3O™ - Dual Mobility System	OR3O™ Dual Mobility in subjects who undergo Primary THA.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months	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).

Secondary Outcome Measures

Name	Time	Method
Survivorship of the OR3O™ Dual Mobility System	6 weeks, 3 months, 6 months, and 12 months	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.
Harris Hip Score (HHS)	Preoperative, 6 weeks, 6 months, and 12 months	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).
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score	Preoperative, 6 weeks, 6 months, and 12 months	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).
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score	Preoperative, 6 weeks, 6 months, and 12 months	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.
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)	Preoperative, 6 weeks, 6 months, and 12 months	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).
Radiographic Assessment - Implant Position/Orientation	6 months and 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
Radiographic Assessment - Implant Subsidence/Migration	6 months and 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
Radiographic Assessment - Heterotopic Ossification	6 months and 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)
Radiographic Assessment - Radiolucencies	6 months and 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'.
Radiographic Assessment - Osteolysis	6 months and 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).
Radiographic Assessment - Implant Loosening	6 months and 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
Radiographic Assessment - Stress Shielding	6 months and 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
Radiographic Assessment - Periprosthetic Fractures	6 months and 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.

Trial Locations

Locations (4): Peking University Third Hospital
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Beijing, China
The Third Hospital of Hebei Medical University
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Shijiazhuang, Hebei, China
The First Affiliated Hospital of Xinjiang Medical University
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Xinjiang, China
The Ninth People's Hospital affiliated to Shanghai Jiao Tong University Medical College
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Shanghai, China