Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL PLUS (study group).
We compare primary and secondary stability of both hip stems for radiographic outcome using EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings.
This study is a monocentric study, randomized and controlled including two types of hip stems: SL PLUS MIA (control group) and SL PLUS (study group).
Each group will include 45 patients where a number of 5 patients for each group calculated extra in case of loss.
Patients will be followed after
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings such as radiolucent lines.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIP STEM SL PLUS | Sham Comparator | study group |
|
| HIP STEM SL PLUS MIA | Active Comparator | control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| primary total hip arthroplasty | Procedure | All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stability of primary total hip arthroplasty | Study compares the stability of two types of hip stems using the Femoral Component Analysis (FCA-EBRA)method. 4 images of a-p pelvic view will be collected over a 2-year period: at 6 weeks, 6, 12 and 24 months. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Hip Score | According to Delaunay C, Cross-cultural adaptations of the Oxford-12 HIP score to the French speaking population, Orthop Traumatol Surg Res. 2009 Apr;95(2):89-99. Epub 2009 Apr 3. Oxford Hip Score will be measured pre-operatively, after 6 weeks, 6, 12 and 24 months. | 24 months |
| Harris Hip Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Henri Migaud, MD, Pr. | University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Salengro, Service d'Orthopédie C | Lille | 59037 | France |
Not provided
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks. |
| 24 months |
| D012216 |
| Rheumatic Diseases |