Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biomet Denmark Aps | UNKNOWN |
| Project coordinator Orthopaedic Centre, Aarhus | UNKNOWN |
| Aarhus University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite.
This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite. A 5-year radiologic analysis of migration will be carried out with the object of detecting prognostic evidence of prosthesis loosening. Migration is determined by Roentgen Stereo-photogrammetric Analysis (RSA) on stereoroentgenography. Simultaneously, the patients will be monitored by using the clinical outcome measure HOOS (Hip disability and osteoarthritis outcome score), OHS (Oxford Hip Score), EQ-5D (EuroQol), HHS (Harris Hip Score) on range of motion, VAS (Visual Analog Scale), postoperative complications and reoperation.
Hypothesis: We expect that the Exceed cup with hydroxyapatite deposited electrochemically (BoneMaster) is superior or equal compared to a similar cup without hydroxyapatite regarding
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthesis, BoneMaster-Exceed cup | Active Comparator | Prosthesis, BoneMaster-Exceed cup: A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) |
|
| Prosthesis Exceed cup without HA | Active Comparator | Prosthesis Exceed cup without HA: A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prosthesis, BoneMaster-Exceed cup (Biomet) | Device | Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic: Migration of the acetabular component (mm, degree) with Model-Based RSA (m-RSA) | End of study (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation of affected hips | End of study (up to 5 years) | |
| Postoperative complications (up to 5 years) | End of study | |
| HOOS (Hip disability and osteoarthritis outcome score) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Orthopaedic
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kjeld Soballe, Prof, dr med | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36422666 | Derived | Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prosthesis Exceed cup without HA (Biomet) | Device | Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating. |
|
| End of study (up to 5 years) |
| OHS (Oxford Hip Score) | End of study (up to 5 years) |
| HHS (Harris Hip Score) on Range Of Motion (ROM) | End of study (up to 5 years) |
| VAS (Visual Analog Scale) at rest and load | End of study (up to 5 years) |
| EQ-5D (EuroQol) | End of study (up to 5 years) |
| Radiologic osteolysis | End of study (up to 5 years) |