degeneration of the hipjoint osteoarthritis of the hip
Conditions
Interventions
Implanting a total hip prosthesis
the femoral part being a noncemented CFP
prosthesis or a cemented SPII prosthesis.
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients who signed the informed consent 2. Patients older than 70 years at the time of the operation 3. Patients who have symptomatic osteoarthritis of the hip and eligible for a total hip arthroplasty 4. Patients need to be physically and mentally capable to attend the follow up visits or have a partner of caretaker to make sure these visits can be met.
Exclusion criteria
Exclusion criteria: 1. Standard contraindications, as prevailing for elective cemented total hip arthroplasty (infection, severe comorbidity of pulmonary, cardiac or metabolic nature) 2. History of arthrodesis 3. Neurological disorders influencing walking ability. 4.Femur Dorr type 3 (calculated by the Flare index) 5. Cognitive disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical result of the CFP is equal or better than the clinical result of the SPII prosthesis in patients with coxarthrosis of 70 years or older. Primary outcome will be clinical effectiveness, measured with the HOOS classification. Definition of success of the individual patient is: clinical non-relevant difference as 9-point difference or less on the HOOS pain scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| a. secondary outcome measures (base line values, VAS, SF-36, HHS during the total follow up period and in numbers of peri- and postoperative complications, revision rate, bone density, blood loss and incidence of the Trendelenburg sign) of the CFP prostheses are equivalent or better than of the SPII prostheses. b. The operation procedure of the CFP prosthesis is significant shorter than that of the SPII prosthesis (non-inferiority). c. The x-ray and bone density parameters are different in the CFP patient population in de midterm follow up compared to the SPII group. | — |
Countries
Netherlands
Outcome results
None listed