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 goal of this study is to study the stability of the Delta-TT cup with polyethylene insert and the Delta-TT cup with ceramic insert both combined with the H-MAX femoral stem by means of RSA to assess whether the differences in stiffness of the cup will have an influence on incorporation and mechanical stability.
It is hypothesized that there will be more micromotion on the short-term (<2 years) in the patients with the ceramic insert because of the higher stiffness, however, all components will be considered stable on the short and long-term.
Rationale: Roentgen Stereophotogrammetric Analysis (RSA) is a very accurate measurement technique used to obtain micromotion of the implants relative to inserted tantalum markers in the surrounding bone. Using RSA, long-term predictions of prosthetic loosening can be made based on a two years follow-up. Therefore, it is recommended to analyse all (new) prosthetic components by means of RSA.
Objective: The goal of this study is to study in a randomised trial the stability of the Delta-TT cup with polyethylene insert and the Delta-TT cup with ceramic insert both combined with the H-MAX femoral stem by means of RSA to assess whether the differences in stiffness of the cup will have an influence on incorporation and mechanical stability. It is hypothesized that there will be more micromotion on the short-term (<2 years) in the patients with the ceramic insert because of the higher stiffness, however, all components will be considered stable on the short and long-term. Secondary goal is to compare the stability of the C2 femoral stem, to the H-MAX femoral stem as well as to compare it to relevant migration results of similar stems from the literature. These RSA results will contribute to knowledge about the early stability and long-term prosthetic loosening of these cementless stems.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H-MAX stem & Delta-TT cup + polyethylene | Active Comparator | H-MAX femoral stem and the Delta-TT cup with polyethylene insert |
|
| H-MAX stem & Delta-TT cup + ceramic | Experimental | H-MAX femoral stem and the Delta-TT cup with ceramic insert |
|
| C2 stem & Delta-TT cup + ceramic | Experimental | C2 femoral stem and the Delta-TT cup with ceramic insert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H-MAX stem & Delta-TT cup + polyethylene | Device | H-MAX femoral stem & Delta-TT cup with a polyethylene insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in stability | Stability will be assessed with Roentgen Stereophotogrammetric Analysis (RSA). RSA will be used to determine the micromotion of the femur and cup components with respect to the bone.The RSA data of the components will be described in terms of translational and rotational movements. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Quality of Life | Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D) | 2 years |
| Change from Baseline in Quality of Life | Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rudolf W Poolman, MD PhD | Onze Lieve Vrouwe Gasthuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouwe Gasthuis | Amsterdam | North Holland | 1090 HM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39160668 | Derived | Klaassen AD, van Loon J, Willigenburg NW, Koster LA, Kaptein BL, van der Hulst VPM, Haverkamp D, Moojen DJF, Poolman RW. Comparison of 5-year cup and stem migration between ceramic-on-ceramic and ceramic-on-polyethylene bearing in press-fit total hip arthroplasty: a randomised controlled trial using radiostereometric analysis. Hip Int. 2024 Nov;34(6):701-716. doi: 10.1177/11207000241265653. Epub 2024 Aug 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| H-MAX stem & Delta-TT cup + ceramic | Device | H-MAX femoral stem & Delta Delta-TT cup with a Ceramic insert |
|
| C2 stem & Delta-TT cup + ceramic | Device | C2 femoral stem Delta Delta-TT cup with a Ceramic insert |
|
| 5 years |
| Change from Baseline in Physical Function | Physical Function will be assessed with the Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS) | 2 years |
| Change from Baseline in Physical Function | Physical Function will be assessed with the Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS) | 5 years |
| Change from Baseline in Physical Function and Pain | Physical Function will be assessed with the Oxford Hip Score (OHS) | 2 years |
| Change from Baseline in Physical Function and Pain | Physical Function will be assessed with the Oxford Hip Score (OHS) | 5 years |
| Change from Baseline in Pain | Pain will be assessed with a Numeric Rating Scale (NRS) | 2 years |
| Change from Baseline in Pain | Pain will be assessed with a Numeric Rating Scale (NRS) | 5 years |