Avascular Necrosis, Bridging of Large Bone Defects, Femur Fracture, Fracture, Proximal Humeral, Functional Deformities, Osteoarthritis, Provision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies), Pseudarthrosis, Pseudoarthrosis, Revision of Endoprosthesis-treated Hips, Revisions, Rheumatoid Arthritis, Trochanteric Fractures
Conditions
Keywords
Revision total hip arthroplasty, Medical Device, Post Market Surveillance Study, Primary total hip arthroplasty
Brief summary
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and revision total hip arthroplasty.
Detailed description
This multi-center, prospective, non-controlled, consecutive cohort post market surveillance study will serve the purpose of confirming long-term safety and performance of the Hyperion® system. The performance of the Hyperion® THA System will be evaluated using standard scoring systems (Merle d'Aubigné Score, HOOS Score). Safety will be evaluated by adverse event reporting. The study will be performed at 6 sites, enrolling in total 70 patients. Follow-up visits are planned after 3 to 6 month, 1, 2 and 5 years. The scores will be filled in pre-operatively and post-operatively until 5 years. In order to obtain mid- to long-term patient satisfaction data the patient questionnaire will be send to the patient at 7 and 10 years, additionally. Xrays will be done pre-operatively, immediate post-operatively and at each of the Follow-up visits.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient age at least 18 years * Fully conscious and capable patients * Signed informed consent * Stationary treatment * Merle d'Aubigné \< 12 Points, WOMAC Score \> 25 Points * Patients with at least one of the following indications: Indications for primary hip replacement: * Non-inflammatory diseases of the joints such as osteoarthritis and avascular necrosis (head necrosis) * Rheumatoid arthritis * Functional deformities * Provision of non-endoprosthetic previous operations of the hip joint (e.g., transposition osteotomies) * Treatment of pseudarthrosis, femoral neck and trochanter fractures, as well as fractures of the proximal femur affecting the head, which can not be treated by other techniques Revision THA: * Revision of endoprosthesis-treated hips as a result of septic or aseptic loosening, sub- and periprosthetic fractures or material failure (eg fracture of the prosthesis) * Bridging of large bone defects (precondition: suitable proximal bone situation for a stable anchorage), i.e. for tumors
Exclusion criteria
* Infections * Patients under 18 years * Pregnant or breastfeeding patients * Known alcohol abuse (at least 20 g alcohol per day for women and at least 40 g per day for men) or drug abuse * Legal incapacity or restricted capacity * Participation in another clinical trial within the last 30 days or planned participation in another clinical trial within the next 3 months * Patients who are unable to attend to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points. | baseline/Pre-op and 2 years (+/- 2 months) | Pain and walking ability determined by a Merle d' Aubigné Score (MdA) increase of \>4 points compared to the pre-operative score points. The patients were evaluated by the Merle d'Aubigné hip score, which evaluates pain, gait and mobility, on a scale of 1 to 6 for each item, where 1 indicates the worst and 6, the best state of the patient. The value of each item is summed to a total score. The total minimum score reached is 3, and the maximum is 18. Higher scores mean a better outcome. |
| Implant Survival Measured by the Number of Revisions. | 2 years (+/- 2 month) | Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method. |
| WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value | baseline/Pre-op and 2 years (+/- 2 months) | at 2-years post op, WOMAC score (Western Ontario and McMaster Universities Arthritis Index) has to be at least 25 points lower compared to preop values Scale: min 0-Max 100; Higher values mean worse outcome |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients, Suffering From Severe Hip Pain and Disability Patients in need of a total hip arthroplasty | 61 |
| Total | 61 |
Baseline characteristics
| Characteristic | Patients, Suffering From Severe Hip Pain and Disability | — |
|---|---|---|
| Age, Continuous | 72.1 years STANDARD_DEVIATION 8.8 | — |
| BMI | 28.9 kg/m^2 STANDARD_DEVIATION 5.5 | — |
| Operative Side LEFT | 28 Participants | — |
| Operative Side RIGHT | 31 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 61 participants | — |
| Sex: Female, Male Female | 35 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 70 |
| other Total, other adverse events | 33 / 70 |
| serious Total, serious adverse events | 38 / 70 |
Outcome results
Primary
Implant Survival Measured by the Number of Revisions.
Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method.
Time frame: 2 years (+/- 2 month)
Population: number of revisions at 2 years
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Patients, Suffering From Severe Hip Pain and Disability | Implant Survival Measured by the Number of Revisions. | 11 implants |
Primary
Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.
Pain and walking ability determined by a Merle d' Aubigné Score (MdA) increase of \>4 points compared to the pre-operative score points. The patients were evaluated by the Merle d'Aubigné hip score, which evaluates pain, gait and mobility, on a scale of 1 to 6 for each item, where 1 indicates the worst and 6, the best state of the patient. The value of each item is summed to a total score. The total minimum score reached is 3, and the maximum is 18. Higher scores mean a better outcome.
Time frame: baseline/Pre-op and 2 years (+/- 2 months)
Population: MdA score not available for all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients, Suffering From Severe Hip Pain and Disability | Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points. | 6.3 score on a scale | Standard Deviation 3.7 |
| Patients, Suffering From Severe Hip Pain and Disability 1 | Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points. | 13.8 score on a scale | Standard Deviation 2.8 |
Primary
WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value
at 2-years post op, WOMAC score (Western Ontario and McMaster Universities Arthritis Index) has to be at least 25 points lower compared to preop values Scale: min 0-Max 100; Higher values mean worse outcome
Time frame: baseline/Pre-op and 2 years (+/- 2 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients, Suffering From Severe Hip Pain and Disability | WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value | 66.8 score on a scale | Standard Deviation 22.4 |
| Patients, Suffering From Severe Hip Pain and Disability 1 | WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value | 27.5 score on a scale | Standard Deviation 20.9 |