Roentgen Stereophotogrammetric Analysis Osteoarthritis Primary total hip replacement Prothesis Cup Stability
Conditions
Interventions
Randomized trial:
• Group A: 25 patients will receive the H-MAX femoral stem and the Delta-TT cup with polyethylene insert.
• Group B: 25 patients will receive the H-MAX femoral stem and the Delta-T
Sponsors
Link Nederland
Havenstraat 30
3115 HD Schiedam
The Netherlands
Phone: +31(0) 10 246 26 95
Fax: +31(0) 10 246 26 96
info@linknederland.nl
Eligibility
Inclusion criteria
Inclusion criteria: Patients scheduled to undergo primary total hip replacement. Patient is able to understand the meaning of the study and is willing to sign the EC approved, study-specific Informed Patient Consent Form. Ability and willingness to follow instructions and to return for follow-up evaluations. The subject is a male or non-pregnant female between 18 and 75 years of age.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. The subject will be operated bilaterally. Patients having a deformity or disease located in other joints than the hip that needs surgery and is limiting their ability to walk. The subject has an active or suspected latent infection in or about the hip joint. Patient who is expected to need lower limb joint replacement for another joint within one year. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. The subject’s bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. Female patients planning a pregnancy during the course of the study. The patient is unable or unwilling to sign the Informed Consent specific to this study. Subject deemed unsuitable for participation in the study based on the investigator’s judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the early stability of the Delta-TT cup with Polyethylene insert, the Delta-TT cup with Ceramic insert and the H-MAX femoral stem after two years by means of RSA. The RSA migration data of the components will be described in terms of translational and rotational movements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameter is the stability of the C2 femoral stem and compare the migration results with the migration results of the H-MAX femoral stem as well as relevant migration results of similar stems from the literature. The RSA migration data of the components will be described in terms of translational and rotational movements. The third study parameter is to predict the long-term survival of the different implants based on the two and five-year migration patterns and correlate the clinical factors, clinical scores and radiographic aspects with the RSA results. | — |
Contacts
Public ContactR.W. Poolman
Onze Lieve Vrouwe Gasthuis Amsterdam Department of Orthopaedic Surgery Postbus 95500
Outcome results
None listed