Avascular Necrosis of Hip, Dislocated Hip, Fracture of Hip, Osteoarthritis, Hip, Osteonecrosis, Post-traumatic; Arthrosis, Rheumatoid Arthritis, Subluxation Hip
Conditions
Brief summary
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.
Detailed description
The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records. Data will be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the Stafit Acetabular System in primary total hip arthroplasty. The study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the Stafit Acetabular System.
Interventions
DEVICEPatients who received the Stafit Acetabular System
Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Males and females * Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty. * 18 years minimum * Patients able to participate in a follow-up program based upon physical examination and medical history * Patients who have provided written informed consent by signing the Patient Informed Consent Form.
Exclusion criteria
* Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program * Known pregnancy * Revision hip arthroplasty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival | 3 years postoperatively, due to early study termination | Represents the implants that survived by counting the number of implants revised. |
| Dislocation Rate | 2 years | Assessed by counting the number of implant dislocations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Pain and Functional Performance Determined by the Harris Hip Score | 3 years postoperatively, due to early study termination | The Harris Hip Score is a questionnaire filled by the surgeon on the patients who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stairs, public transportation, sitting, and managing shoes and socks) and gait (limp, support needed for walking, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a minimum of 0 (worst possible score) to a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). |
| Confirmation of Safety Based on Complications | 3 years postoperatively, due to early study termination | Reported number of patients with adverse events related to the implant. Adverse events include: dislocations of the hip, revisions and removals of the implants |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Who Received the Stafit Acetabular System Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria. | 166 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study prematuely terminated. | 166 |
Baseline characteristics
| Characteristic | Patients Who Received the Stafit Acetabular System | — |
|---|---|---|
| Age, Continuous | 73.9 years STANDARD_DEVIATION 7.9 | — |
| Body Mass Index (kg/m2) | 27.0 kg/m^2 STANDARD_DEVIATION 5.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 116 Participants | — |
| Sex: Female, Male Male | 50 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 166 |
| other Total, other adverse events | 11 / 166 |
| serious Total, serious adverse events | 10 / 166 |
Outcome results
Primary
Dislocation Rate
Assessed by counting the number of implant dislocations
Time frame: 2 years
Population: Count of the number of dislocations 2 years postoperatively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Received the Stafit Acetabular System | Dislocation Rate | 0 Implant Dislocations |
Primary
Implant Survival
Represents the implants that survived by counting the number of implants revised.
Time frame: 3 years postoperatively, due to early study termination
Population: Outcome Measure Data at 3 years postoperative (Study early terminated). The Kaplan-Meier survival rate with cup revision for any reason.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Received the Stafit Acetabular System | Implant Survival | 100 percentage of implant survival |
Secondary
Confirmation of Safety Based on Complications
Reported number of patients with adverse events related to the implant. Adverse events include: dislocations of the hip, revisions and removals of the implants
Time frame: 3 years postoperatively, due to early study termination
Population: Outcome Measure Data at 3 years postoperative (Study early terminated). Record of any adverse events related to the Stafit Acetabular System.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Received the Stafit Acetabular System | Confirmation of Safety Based on Complications | 1 study patients |
Secondary
Evaluation of Pain and Functional Performance Determined by the Harris Hip Score
The Harris Hip Score is a questionnaire filled by the surgeon on the patients who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stairs, public transportation, sitting, and managing shoes and socks) and gait (limp, support needed for walking, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a minimum of 0 (worst possible score) to a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Time frame: 3 years postoperatively, due to early study termination
Population: Outcome Measure Data at 3 years postoperative (Study early terminated). Number Of Unilateral Participants: 48 Unilaterals; Number Of Bilateral Participants : 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Received the Stafit Acetabular System | Evaluation of Pain and Functional Performance Determined by the Harris Hip Score | 91.5 score on a scale | Standard Deviation 10.3 |