Hip Osteoarthritis
Conditions
Keywords
NIDJD, osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of pelvis, diastrophic variant, non-inflammatory arthritis
Brief summary
The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation
Detailed description
This is a prospective, multi-center, interventional, randomized controlled study to investigate the safety and efficacy of the OXINIUM◊ DH Hip System (Smith & Nephew, Inc., Memphis, TN, USA). The study will follow all enrolled Subjects for 3 years and investigational Subjects for 10 years (primary safety endpoint) in total. Subjects meeting inclusion and exclusion criteria will receive THA and will be randomized to receive implantation of the Investigational or Control Device. The post-operative rehabilitation will be per standard of care at the treating institution. Up to 20 US and 10 out-of-US (OUS) enrolling investigational sites will participate in this study.
Interventions
DEVICEOXINIUM DH Hip System
Investigational Group: OXINIUM DH Hip System
DEVICEBIOLOX◊
Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Age between 22 and 79 years, inclusive; * Subject is skeletally mature in Investigator's judgment; * Subject has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant requiring unilateral primary total hip replacement; * Preoperative (within 28 days prior to the surgery) total Harris Hip Score of less than 70; * Subject is a suitable candidate for primary total hip replacement at the discretion of the investigator; * Subject has given consent to participate in the study after the nature, scope, and possible consequences of the study have been explained in an understandable form; * Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.
Exclusion criteria
* Subject has had a previous total hip replacement, hemi-arthroplasty, or fusion in either hip; * Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations in the other (not study) hip; * Subject has a known allergy to any component of the devices used in the study; * Subject with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible; * Subject with total or partial absence of the muscular or ligamentous apparatus of the hip joint to be operated; * Subject has a congenital disorder or deformity of the affected limb or significant anatomic variance of the affected hip (based on Investigator's discretion); * Subject has an active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. * Subjects with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study; * Subject has rheumatoid arthritis; * Subject has a Body Mass Index \> 40; * Subject has an active infection (e.g. hepatitis, Acquired Immunodeficiency Syndrome, AIDS related Complex) - systemic or at the site of intended surgery; * Subject has contralateral lower extremity condition causing abnormal ambulation and noncompliance with rehabilitation; * Prior proximal femur fracture and/or presence of malunion, nonunion, and the surgical side; * Subject has conditions that may interfere with THA survival or outcome (e.g., Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes defined by HgbA1c \> 7%, or neuromuscular disease); * Subject has systemic steroid therapy with 1 month prior to surgery; * Subject is on drug therapy for the index hip with intra-articular corticosteroid therapy or any intra-articular therapy within 3 months of enrollment into the study; * Subject has a life expectancy less than 10 years; * Subject is female and of child bearing age who is currently pregnant or not using contraception; * Subject has known moderate to severe renal insufficiency; * Subject has an emotional 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 is entered in another investigational drug, biologic, or device study within 30 days of active study participation; * Subject is unable, unwilling, or in the Investigator's opinion unlikely to return for or participate in follow-up visits at the investigational site; * Subject is facing current or impending incarceration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Success at 730 Days Post-operative in Participants With a Unilateral Hip Implant | 730 days | To be classified as overall success, the participant must meet all of the following criteria: * Clinical Success * Harris Hip Score of 80 or more at the 730-day follow-up time point. * Radiologic success at the 730-day follow-up time point defined as: * No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones, and * No femoral or acetabular subsidence greater than or equal to 5mm from baseline, and * No acetabular cup inclination changes greater than 4 degrees. * Absence of Revision * No reoperations that led to removal or replacement of any of the acetabular or femoral components |
| Number of Unilateral Hip Implant Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points | 730 days | The number of participants with a modified Harris Hip Score (mHHS) greater than or equal to 80 points. The Harris Hip Score (HHS) 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. The mHHS includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranged from 0 (worst) to 95 (best). |
| Radiographic Success at 730 Days Postoperative - Radiolucencies in Participants With a Unilateral Hip Implant | 730 days | Number of participants with radiographic success for radiolucencies where success indicated no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones. |
| Radiographic Success at 730 Days Postoperative - Femoral or Acetabular Subsidence in Participants With a Unilateral Hip Implant | 730 days | Number of participants with radiographic success for femoral or acetabular subsidence where success indicated no femoral or acetabular subsidence greater than or equal to 5 millimeters (mm) from baseline. |
| Radiographic Success at 730 Days Postoperative - Acetabular Cup Inclination in Participants With a Unilateral Hip Implant | 730 days | Number of participants with radiographic success for acetabular cup inclination where success indicated no acetabular cup inclination changes greater than 4 degrees. |
| Number of Unilateral Hip Implant Participants With Absence of Revision at 730 Days Postoperative | 730 Days | Number of participants with absence of revision defined as no reoperations that led to removal or replacement of any of the acetabular or femoral components. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 730 Days Postoperatively | Baseline to 730 days | The WOMAC is a 24 item subject-reported self-assessment questionnaire. It evaluates pain (5 questions), stiffness (2 questions), and functional limitation (17 questions) in knee and hip osteoarthritis. In this study, version 3.0 of the instrument is used, which employs a 5-point Likert scale ranging from none (0) to extreme (4). The Functional Limitations Score takes values from 0 (no problems) to 68 (extreme problems). Scores are transformed to a score from 0 to 100, with a lower score indicating a better outcome. |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 9.3 |
| Body Mass Index (BMI) | 28.4 kg/m^2 STANDARD_DEVIATION 5 |
| Medical History - Primary Diagnosis Avascular necrosis | 4 Participants |
| Medical History - Primary Diagnosis Osteoarthritis | 195 Participants |
| Medical History - Primary Diagnosis Other | 2 Participants |
| Medical History - Primary Diagnosis Traumatic arthritis | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants |
| Race/Ethnicity, Customized Race Black | 42 Participants |
| Race/Ethnicity, Customized Race Other | 11 Participants |
| Race/Ethnicity, Customized Race White | 354 Participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 183 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 205 | 1 / 208 |
| other Total, other adverse events | 114 / 205 | 92 / 208 |
| serious Total, serious adverse events | 56 / 205 | 41 / 208 |
Outcome results
None listed