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
Not provided
The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi⢠G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1⢠liner, allowing for the largest possible femoral head (36mm-44mm) to E1⢠liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsseoTi⢠G7 large | Active Comparator | OsseoTi⢠G7 acetabular cup and an E1⢠liner holding largest possible femoral head (36mm-44mm) |
|
| OsseoTi⢠G7 32 | Active Comparator | OsseoTi⢠G7 acetabular cup and an E1⢠insert holding a 32mm femoral head |
|
| conventional PPS coated G7 large | Active Comparator | conventional PPS coated G7 acetabular cup and an E1⢠insert holding largest possible femoral head (36mm-44mm) |
|
| conventional PPS coated G7 32 | Active Comparator | conventional PPS coated G7 acetabular cup and an E1⢠insert holding a 32mm femoral head |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THA with G7 PPS coted acetabular component | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA. | Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns. | 2 year |
Not provided
Not provided
Inclusion Criteria:
⢠Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre | Hvidovre | 2650 | Denmark | |||
| Sahlgrenska University Hospital, Department of Orthopedics, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38350518 | Derived | Tsikandylakis G, Mortensen KRL, Gromov K, Mohaddes M, Malchau H, Troelsen A. The Use of Large Metal Heads in Thin Vitamin E-Doped Cross-Linked Polyethylene Inserts Does Not Increase Polyethylene Wear in Total Hip Arthroplasty: 5-Year Results From a Randomized Controlled Trial. J Arthroplasty. 2024 Jul;39(7):1804-1810. doi: 10.1016/j.arth.2024.02.008. Epub 2024 Feb 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| THA with G7 OsseoTi coted acetabular component | Device |
|
| Gothenburg |
| SW-431 80 |
| Sweden |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided