Avascular Necrosis of Hip, Inflammatory Arthritis, Osteoarthritis, Hip, Post-Traumatic Osteoarthritis of Hip
Conditions
Keywords
Total hip arthroplasty, Medical Device, Safety, Hip prosthesis
Brief summary
This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
Detailed description
The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System. A total of 200 patients are planned to be enrolled in this study which will last 12 years (2 year enrollment plus 10 years follow-up) with the follow-up visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.
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 18 to 75 years of age, inclusive. * 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 |
|---|---|---|
| Survivorship | 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 calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component. |
| Safety of the Implant | Up to 10 years postoperative | Will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) b) Efficacy: |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-12 Physical and Mental Functional Scores | pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year | The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning and lower scores indicating worse physical and mental health functioning. |
| Harris Hip Score | 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 |
| Radiographic Evaluations | 10 Years post-surgery | Radiographic evaluation was done to assess (radiolucency, osteolysis, subsidence, cup migration, change in cup angle and change in femoral shaft angle) of study subjects who received the Allofit IT Acetabular System |
| 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) |
| EQ-5D | 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. 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. |
Countries
Germany, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Who Received the Allofit IT With BIOLOX Delta Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners | 184 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 6 |
| Overall Study | Lost to Follow-up | 29 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Patients Who Received the Allofit IT With BIOLOX Delta | — |
|---|---|---|
| Age, Continuous | 56.4 Age (years) at date of surgery STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 136 participants | — |
| Region of Enrollment Sweden | 48 participants | — |
| Sex: Female, Male Female | 66 Participants | — |
| Sex: Female, Male Male | 118 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 185 |
| other Total, other adverse events | 52 / 185 |
| serious Total, serious adverse events | 45 / 185 |
Outcome results
Primary
Safety of the Implant
Will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) b) Efficacy:
Time frame: Up to 10 years postoperative
Population: The count of all participants with adverse events is summarized. Details are available in the Adverse Event overview of the results section
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Received the Allofit IT With BIOLOX Delta | Safety of the Implant | Hip Related complications (AE and SAE) | 9 Participants |
| Patients Who Received the Allofit IT With BIOLOX Delta | Safety of the Implant | Revisions | 6 Participants |
| Patients Who Received the Allofit IT With BIOLOX Delta | Safety of the Implant | SAE's not related to study hip | 38 Participants |
Primary
Survivorship
The objective of this study is implant survival at 10 years which is assessed by revision of the the study device calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.
Time frame: 10 years post-surgery
Population: All study patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Received the Allofit IT With BIOLOX Delta | Survivorship | 179 Implants |
Secondary
EQ-5D
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. 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.
Time frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Population: The number of participants decreased over time, reasons are: questionnaire not completed in full (score calculation not possible), missed visits, lost to follow-up or withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Allofit IT With BIOLOX Delta | EQ-5D | 1 Year | 0.9 score on a scale | Standard Deviation 0.2 |
| Patients Who Received the Allofit IT With BIOLOX Delta | EQ-5D | pre-op | 0.4 score on a scale | Standard Deviation 0.3 |
| Patients Who Received the Allofit IT With BIOLOX Delta | EQ-5D | 6 months | 0.9 score on a scale | Standard Deviation 0.2 |
| Patients Who Received the Allofit IT With BIOLOX Delta | EQ-5D | 2 Year | 0.9 score on a scale | Standard Deviation 0.2 |
| Patients Who Received the Allofit IT With BIOLOX Delta | EQ-5D | 3 Year | 0.9 score on a scale | Standard Deviation 0.2 |
| Patients Who Received the Allofit IT With BIOLOX Delta | EQ-5D | 5 Year | 0.8 score on a scale | Standard Deviation 0.2 |
| Patients Who Received the Allofit IT With BIOLOX Delta | EQ-5D | 7 Year | 0.8 score on a scale | Standard Deviation 0.2 |
| Patients Who Received the Allofit IT With BIOLOX Delta | EQ-5D | 10 Year | 0.8 score on a scale | Standard Deviation 0.2 |
Secondary
Harris Hip Score
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
Time frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Population: All study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Allofit IT With BIOLOX Delta | Harris Hip Score | Pre-op | 48.8 score on a scale | Standard Deviation 11.5 |
| Patients Who Received the Allofit IT With BIOLOX Delta | Harris Hip Score | 6 months | 93.2 score on a scale | Standard Deviation 11.3 |
| Patients Who Received the Allofit IT With BIOLOX Delta | Harris Hip Score | 1 Year | 96.1 score on a scale | Standard Deviation 7.9 |
| Patients Who Received the Allofit IT With BIOLOX Delta | Harris Hip Score | 2 Year | 96.9 score on a scale | Standard Deviation 6.9 |
| Patients Who Received the Allofit IT With BIOLOX Delta | Harris Hip Score | 3 Year | 96.1 score on a scale | Standard Deviation 9 |
| Patients Who Received the Allofit IT With BIOLOX Delta | Harris Hip Score | 5 Year | 95.2 score on a scale | Standard Deviation 9.5 |
| Patients Who Received the Allofit IT With BIOLOX Delta | Harris Hip Score | 7 Year | 96.0 score on a scale | Standard Deviation 8.3 |
| Patients Who Received the Allofit IT With BIOLOX Delta | Harris Hip Score | 10 Year | 93.9 score on a scale | Standard Deviation 11.3 |
Secondary
Radiographic Evaluations
Radiographic evaluation was done to assess (radiolucency, osteolysis, subsidence, cup migration, change in cup angle and change in femoral shaft angle) of study subjects who received the Allofit IT Acetabular System
Time frame: 10 Years post-surgery
Population: All study patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Received the Allofit IT With BIOLOX Delta | Radiographic Evaluations | Stem Subsidence (0.2mm - 6mm) | 11 Participants |
| Patients Who Received the Allofit IT With BIOLOX Delta | Radiographic Evaluations | Radiolucency (>2mm) | 4 Participants |
| Patients Who Received the Allofit IT With BIOLOX Delta | Radiographic Evaluations | Cup Migration (0.3mm - 0.9mm) | 6 Participants |
| Patients Who Received the Allofit IT With BIOLOX Delta | Radiographic Evaluations | Osteolysis | 1 Participants |
| Patients Who Received the Allofit IT With BIOLOX Delta | Radiographic Evaluations | Heterotopic Ossification (Class III and class IV) | 3 Participants |
| Patients Who Received the Allofit IT With BIOLOX Delta | Radiographic Evaluations | Calcar Resorption (0.3mm - 5mm) | 9 Participants |
Secondary
SF-12 Physical and Mental Functional Scores
The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning and lower scores indicating worse physical and mental health functioning.
Time frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Population: All study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | Pre-op, SF12 Physical | 28.8 score on a scale | Standard Deviation 7.1 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 6 months, SF12 Physical | 46.5 score on a scale | Standard Deviation 9.9 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 1 Year, SF12 Physical | 48.5 score on a scale | Standard Deviation 8.9 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 2 Year, SF12 Physical | 49.5 score on a scale | Standard Deviation 9.3 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 3 Year, SF12 Physical | 47.0 score on a scale | Standard Deviation 10.6 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 5 Year, SF12 Physical | 46.9 score on a scale | Standard Deviation 9.8 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 7 Year, SF12 Physical | 47.2 score on a scale | Standard Deviation 10.8 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 10 Year, SF12 Physical | 47.3 score on a scale | Standard Deviation 9.9 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | Pre-op, SF12 Mental | 44.9 score on a scale | Standard Deviation 11.8 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 6 months, SF12 Mental | 55.7 score on a scale | Standard Deviation 7.9 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 1 Year, SF12 Mental | 55.0 score on a scale | Standard Deviation 7.8 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 2 Year, SF12 Mental | 55.6 score on a scale | Standard Deviation 7.2 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 3 Year, SF12 Mental | 54.6 score on a scale | Standard Deviation 8.4 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 5 Year, SF12 Mental | 54.1 score on a scale | Standard Deviation 9.1 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 7 Year, SF12 Mental | 52.5 score on a scale | Standard Deviation 10.4 |
| Patients Who Received the Allofit IT With BIOLOX Delta | SF-12 Physical and Mental Functional Scores | 10 Year, SF12 Mental | 54.2 score on a scale | Standard Deviation 8.1 |
Secondary
UCLA Activity Score
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)
Time frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Population: The number of participants decreased over time, reasons are: questionnaire not completed, missed visits, lost to follow-up or withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Allofit IT With BIOLOX Delta | UCLA Activity Score | Pre-op | 4.3 score on a scale | Standard Deviation 1.6 |
| Patients Who Received the Allofit IT With BIOLOX Delta | UCLA Activity Score | 6 months | 6.1 score on a scale | Standard Deviation 1.7 |
| Patients Who Received the Allofit IT With BIOLOX Delta | UCLA Activity Score | 1 Year | 6.4 score on a scale | Standard Deviation 1.5 |
| Patients Who Received the Allofit IT With BIOLOX Delta | UCLA Activity Score | 2 Year | 6.6 score on a scale | Standard Deviation 1.6 |
| Patients Who Received the Allofit IT With BIOLOX Delta | UCLA Activity Score | 3 Year | 6.2 score on a scale | Standard Deviation 1.7 |
| Patients Who Received the Allofit IT With BIOLOX Delta | UCLA Activity Score | 5 Year | 6.4 score on a scale | Standard Deviation 1.7 |
| Patients Who Received the Allofit IT With BIOLOX Delta | UCLA Activity Score | 7 Year | 6.0 score on a scale | Standard Deviation 1.9 |
| Patients Who Received the Allofit IT With BIOLOX Delta | UCLA Activity Score | 10 Year | 6.4 score on a scale | Standard Deviation 1.7 |