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Change on clinical and marketing strategy for the devices
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm (dual mobility) | Experimental | OR3O™ Dual Mobility in subjects who undergo Primary THA. |
|
| Controlled Arm (conventional) | Active Comparator | A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks, 3 months, 6 months, and 12 months |
| Harris Hip Score (HHS) |
Not provided
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:
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.:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Li Cao | First Affiliated Hospital of Xinjiang Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050051 | China | ||
| Peking University Third Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2020 | Mar 10, 2025 |
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| 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. |
|
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). |
| 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). | 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. | 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). | 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:
| 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:
| 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:
| 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'. | 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). | 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:
| 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:
| 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. | 6 months and 12 months |
| Beijing |
| 100191 |
| China |
| The Ninth People's Hospital affiliated to Shanghai Jiao Tong University Medical College | Shanghai | 200011 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Xinjiang | 830054 | China |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. | Posted | Count of Participants | Participants | 12 months |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Count of Units | hips | 6 weeks, 3 months, 6 months, and 12 months | hips | hips |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 6 weeks, 6 months, and 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 6 weeks, 6 months, and 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 6 weeks, 6 months, and 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 6 weeks, 6 months, and 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | 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:
| 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. | Posted | Count of Participants | Participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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:
| 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. | Posted | Count of Participants | Participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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:
| 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. | Posted | Count of Participants | Participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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'. | 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. | Posted | Count of Participants | Participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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). | 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. | Posted | Count of Participants | Participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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:
| 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. | Posted | Count of Participants | Participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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:
| 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. | Posted | Count of Participants | Participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 6 months and 12 months |
|
Adverse events collected upon device implantation to study termination, up to 12 months (±60 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 11 | 3 | 11 | 3 | 11 |
| EG001 | 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. | 1 | 11 | 3 | 11 | 4 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RIGHTBUTTOCKBOIL | Skin and subcutaneous tissue disorders | Systematic Assessment | Not related to device or procedure |
| |
| HYPOALBUMINEMIA | Blood and lymphatic system disorders | Systematic Assessment | Not related to device or procedure |
| |
| HYDRONEPHROSIS WITH URETERAL STONES | Renal and urinary disorders | Systematic Assessment | Not related to device or procedure |
| |
| HYPOHEMOGLOBIN | Blood and lymphatic system disorders | Systematic Assessment | Not related to device or procedure |
| |
| RESPIRATORY BLEEDING | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not related to device or procedure |
| |
| BLURRED VISION IN THE LEFT EYE WITH DEFORMATION OF VISION FOR OVER SIX MONTHS | Eye disorders | Systematic Assessment | Not related to device or procedure |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 IS POSITIVE | Infections and infestations | Systematic Assessment | Not related to device or procedure |
| |
| LEFT CALF INTERMUSCULAR VEIN THROMBOSIS | Vascular disorders | Systematic Assessment | Not related to device or procedure |
| |
| HYPOKALEMIA | Endocrine disorders | Systematic Assessment | Not related to device or procedure |
| |
| HYPOALBUMINEMIA | Blood and lymphatic system disorders | Systematic Assessment | Not related to device or procedure |
|
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.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | +44 7811 407089 | datasharing.gcs@smith-nephew.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 29, 2024 | Mar 10, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D001172 | Arthritis, Rheumatoid |
| D005265 | Femoral Neck Fractures |
| D005271 | Femur Head Necrosis |
| D010003 | Osteoarthritis |
| D006617 | Hip Dislocation |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004204 | Joint Dislocations |
Not provided
Not provided
| ≥ 60 years |
|
| Male |
|
| Han |
|
| Participants |
|
| hips |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Varus tilted |
|
| Valgus tilted |
|
| Subsidence |
|
| Migration cranial |
|
| Migation medial |
|
| Tilted |
|
| Grade I |
|
| Grade II |
|
| Grade III |
|
| Grade IV |
|
| No |
|
| No |
|
| No loosening |
|
| Possible loosening |
|
| Probable loosening |
|
| Definite loosening |
|
| No |
|
| No |
|
| No |
|
| No |
|