Avascular Necrosis, Inflammatory Arthritis, Osteoarthritis, Hip, Post-Traumatic Osteoarthritis of Hip
Conditions
Keywords
Total hip arthroplasty, Medical Device, Safety, Hip prosthesis
Brief summary
The study design is a multi-center, prospective, non-controlled, consecutive cohort postmarket clinical follow-up study to obtain survival and outcome data on the Allofit IT Shell in combination with Longevity Liners in primary total hip arthroplasty.
Detailed description
The study will involve orthopedic surgeons skilled in total hip arthroplasty and experienced with the implants subject of this study. In total, 5 centers will be involved. This number of clinical sites will permit assessment of the consistency among a multitude of Investigators. A total number of 200 subjects will be included in the study. It is anticipated that each clinical site will enroll 40-60 eligible study subjects, who have provided written informed consent. Ethics Committee (EC) approval for each site has to be obtained prior to conducting this research. Sequentially, all eligible patients will be offered study enrollment at each center to avoid potential selection bias. All potential subjects will be required to participate in an informed consent process and sign an EC approved written informed consent prior to study enrollment. It is anticipated the enrollment period may be 12 months or longer to assure an adequate number of cases at each site. Each case enrolled will receive an Allofit IT HXPE Bearing System. The study is designed to be prospective to ensure that the study population is representative of the type of population that the device is intended to treat. The subjects included will be candidates for All subjects will undergo preoperative clinical, functional and radiographic evaluations, total hip arthroplasty, immediate post-operative evaluations and post-operative clinical, functional and radiographic evaluations at 6 months (± 1 month), 1 year (± 2 months), 2 year (± 2 months), 3 year (± 2 months), 5 year (± 2 months), 7 year (± 2 months), and 10 year (± 2 months).
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient is skeletally mature. * Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following: * Avascular necrosis (AVN) * Osteoarthritis (OA) * Inflammatory arthritis (i.e. Rheumatoid arthritis) * Post-traumatic arthritis * Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s). * Patient has a Harris Hip Score \<70 in the affected hip * Patient is willing and able to provide written informed consent. * Patient is willing and able to cooperate in the required post-operative therapy. * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. * Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent.
Exclusion criteria
* The patient is: * A prisoner * Mentally incompetent or unable to understand what participation in the study entails * A known alcohol or drug abuser * Anticipated to be non-compliant. * The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * The patient has a vascular (large and small vessel disease) insufficiency. * The patient has a neurologic condition in the ipsalateral or contralateral limb which affects lower limb function. * The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome. * The patient is known to be pregnant. * The patient is unwilling or unable to give informed consent, or to comply with the follow-up program. * The patient has received an investigational drug or device within the previous 6 months. * The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously. * The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock. * The patient has osteoradionecrosis in the operative hip joint * The patient has a known sensitivity or allergic reaction to one or more of the implanted materials. * The patient has known local bone tumors in the operative hip. * The patient is Grade III obese with a Body Mass Index (BMI) \> 40.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of the Implant System | 10 years post-surgery | The objective of this study is implant survival at 10 years which is assessed by revision of the the study device. Survivorship at 10 years was defined as cases that had the implant still in place at 10 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the Implant System | 10 years post-surgery | Safety of the system will be assessed by monitoring the frequency and incidence of adverse events. |
| Harris Hip Score (HHS) | pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year | The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70 |
| EQ-5D-3L Score | pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year | The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes five dimensions referring to mobility, self-care, daily activities,pain/discomfort, and anxiety/depression. Each question can be answered in three ways/levels indicating no problems, some problems, and extreme problems. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.594;negative numbers correspond to a self-assessed health state worse than being dead. Higher scores mean a better outcome. |
| EQ-5D VAS | pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year | The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her current state of health. Higher scores mean a better outcome. |
| Oxford Hip Score | pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year | The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27. Higher scores mean a better outcome. |
| UCLA Activity Score | pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year | The case administered University of California at Los Angeles (UCLA) score allows assessment of the case's activity level at each time point with scores from 1 (Wholly inactive: dependent on others; cannot leave residence) to 10 (Regularly participates in impact sports). Higher scores mean a better outcome |
| Radiographic Evaluations - Acetabular Site | pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year | X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence,heterotopic ossification, etc |
| Radiographic Evaluations - Femoral Side | pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year | X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence,heterotopic ossification, etc |
Countries
Austria, France, Germany, Spain
Contacts
STUDY_DIRECTOREmilie Rohmer
Zimmer Biomet
Participant flow
Recruitment details
Enrollment for this study was initiated in 2011 and was completed in 2017. Medizinische Universitat Wien, Universitatsklinik fur Orthopadie, Austria enrolled 41 patients, CHU de Nantes - Site Nord, France enrolled 36 patients, Kliniken Dr. Erler GmbH, Germany enrolled 50 patients, Orthopadie El Masry, Germany enrolled 40 patients and HUA Santiago enrolled 30 patients
Pre-assignment details
Enrollment for this study was initiated in 2011 and was completed in 2017 with 197 patients enrolled in five participating study centers. One site which enrolled 30 patients is inactive since a long time an only has data up to 1-year Post-OP.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 9.2 |
| BMI | 28.0 kg/m² STANDARD_DEVIATION 4.7 |
| Region of Enrollment Austria | 41 participants |
| Region of Enrollment France | 36 participants |
| Region of Enrollment Germany | 90 participants |
| Region of Enrollment Spain | 30 participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 197 |
| other Total, other adverse events | 25 / 197 |
| serious Total, serious adverse events | 52 / 197 |
Outcome results
None listed