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

NCT04941729 | Terminated Results

• 1 other identifier: OR3O.2019.10 (CHINA)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Total Hip Arthroplasty (THA)

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (13)

• Survivorship of the OR3O™ Dual Mobility System

  6 weeks, 3 months, 6 months, and 12 months

• Harris Hip Score (HHS)

  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

  Preoperative, 6 weeks, 6 months, and 12 months

• EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score

  Preoperative, 6 weeks, 6 months, and 12 months

• Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)

  Preoperative, 6 weeks, 6 months, and 12 months

Study Arms (2)

Study Arm (dual mobility)

EXPERIMENTAL

OR3O™ Dual Mobility in subjects who undergo Primary THA.

Device: OR3O™ - Dual Mobility System

Controlled Arm (conventional)

ACTIVE COMPARATOR

A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA.

Device: Conventional

Interventions

OR3O™ - Dual Mobility System DEVICE

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).

Study Arm (dual mobility)

Conventional DEVICE

A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head.

Controlled Arm (conventional)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew Medical (Shanghai) Ltd: lead

Study Sites (4)

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

The Ninth People's Hospital affiliated to Shanghai Jiao Tong University Medical College

Shanghai, 200011, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, 830054, China

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Femoral Neck Fractures; Femur Head Necrosis; Osteoarthritis; Hip Dislocation; Hip Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Dislocations

Limitations and Caveats

Only 22 participants were enrolled due to early termination of the study leading to a small number of participants analyzed for the outcome measures. No reliable conclusions could be made from the data collected and analyzed based on the small number of participants.

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

+44 7811 407089

Study Officials

• Li Cao

  First Affiliated Hospital of Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 28, 2021
• Study Start: June 24, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)