Osteoarthritis
Conditions
Brief summary
Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.
Detailed description
The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™. Efficacy evaluations: * Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) \[7, 8\], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). * Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration Safety evaluations: * Intra- and perioperative device-related adverse events (AE) and complications up to discharge * Postoperative AE up to 10 years
Interventions
DEVICETotal Hip Arthroplasty
Total Hip Arthroplasty using Cementless version of the POLARSTEM
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient has no general medical contraindication to surgery * Informed consent to participate in the MCO signed by the patient * Routine radiographic assessment is possible * Patient is likely to comply with study follow-up requirements * Primary total hip replacement (THR) to the affected side, unilateral or bilateral
Exclusion criteria
* Previously failed endoprosthesis and /or THR components in relevant hip * History of infection in the affected joint; systemic infections * Grossly insufficient femoral or acetabular bone stock in the involved hip * Charcot joint disease or other severe neurosensory deficit * Severe spinal disorders * Age of patient at date of surgery \> 75 years * High comorbidity * Cemented acetabular cup
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM | Pre-operatively, 3 months, 12 months, 36 months, 60 months, and 120 months | Overall survivorship of the Cementless Version of the POLARSTEM pre-operatively, 3 months, 12 months, 12 months, 36 months, 60 months, and 120 months by Kaplan-Meier estimate with overall hip survivorship defined as the time between date of treatment and date of revision for any reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) | Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 months | The HHS measured function, range of motion (ROM), and pain sub-scores that are combined to indicate total dysfunction on a numerical scale from 0 to 100, with a higher score indicating less dysfunction (i.e., a better outcome). Reported scores for the HHS utilized the following grading: * \<70 = poor * 70 to 80 = fair * 80 to 90 = good * 90 to 100 = excellent |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale | Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months | WOMAC Pain subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range of 0 to 20. Higher WOMAC scores indicate worse pain (i.e., worse outcome) and lower scores indicate less pain (i.e., a better outcome). |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale | Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months | WOMAC Stiffness subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range from 0 to 8 with a higher score indicating a worse outcome and a low score indicating a better outcome. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale | Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months | WOMAC Physical Function subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range from 0 to 68 with a higher score indicating a worse outcome and a low score indicating a better outcome. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score | Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months | WOMAC total score combines Stiffness, Pain, and Physical Function subscales of the Hip Disability and Osteoarthritis Outcome Score (HOOS) into a range from 0 to 96 with a higher score indicating a worse outcome and a lower score indicating a better outcome. |
| Radiological: Radiolucent Lines | 3 months, 12 months, 36 months, 60 months, 120 months | Number of hips identified with radiographic findings of radiolucent lines present (Yes/No) in femoral zones 1 to 14. Radiolucent lines indicated seams of 0 millimeters to 2 millimeters or greater. |
| Radiological: Osteolysis | 3 months, 12 months, 36 months, 60 months, 120 months | Number of hips identified with radiographic findings of osteolysis present (Yes/No) in femoral zones 1 to 14. |
| Radiological: Atrophy | 3 months, 12 months, 36 months, 60 months, 120 months | Number of hips identified with radiographic findings for atrophy in femoral zones 1 to 14 indicated as: * None * Mild * Moderate * Severe * Missing |
| Radiological: Hypertrophy | 3 months, 12 months, 36 months, 60 months, 120 months | Number of hips identified with radiographic findings for hypertrophy in femoral zones 1 to 14 indicated as: * None * Mild * Moderate * Severe * Missing |
| Radiological: Loosening of the Implant or Migration | 3 months, 12 months, 36 months, 60 months, 120 months | Number of hips identified with radiographic findings associated with loosening of the implant or migration were indicated as: * Integration not assessable * Indifferent, bone unchanged * Osteointegration, integration * Bone loss * Signs of loosening * Revision indicated |
Countries
Germany, Switzerland
Contacts
PRINCIPAL_INVESTIGATORTurgay Efe, Dr.med.
Philipps University Marburg
Participant flow
Recruitment details
Participants were enrolled at three centers in two countries in Europe (2 in Germany and 1 in Switzerland)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.70 years STANDARD_DEVIATION 7.7 |
| Age, Customized Age Group <= 60 years | 62 Participants |
| Age, Customized Age Group > 60 years | 156 Participants |
| Body Mass Index (BMI) | 28.30 kg/m^2 STANDARD_DEVIATION 4.72 |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 29 / 218 |
| other Total, other adverse events | 115 / 218 |
| serious Total, serious adverse events | 114 / 218 |
Outcome results
None listed