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

NCT ID: NCT04941729

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-24
• Study Completion Date: 2023-11-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Arm (dual mobility)

OR3O™ Dual Mobility in subjects who undergo Primary THA.

Group Type: EXPERIMENTAL

OR3O™ - Dual Mobility System

Intervention Type: 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).

Controlled Arm (conventional)

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

Group Type: ACTIVE_COMPARATOR

Conventional

Intervention Type: 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.

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Medical (Shanghai) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Cao

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Locations

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Peking University Third Hospital

Beijing, , China

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

Shanghai, , China

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OR3O.2019.10 (CHINA)

Identifier Type: -

Identifier Source: org_study_id