Total hip Arthroplasty for Osteoarthritis, Avascular necrosis (AVN), Inflammatory arthritis, Rheumatoid arthritis with adequate bone quality, Post-traumatic arthritis or Congenital hip dysplasia.
Conditions
Interventions
None listed
Sponsors
Department of orthopedic surgery
Eligibility
Inclusion criteria
Inclusion criteria: Patient is 18 to 75 years of age, inclusive • Patient is able to speak and write Dutch • Patient qualifies for primary unilateral total hip arthroplasty (THA) based on physical exam and medical history including at least one of the following: o Osteoarthritis o Avascular necrosis (AVN) o Inflammatory arthritis o Rheumatoid arthritis with adequate bone quality o Post-traumatic arthritis o Congenital hip dysplasia. •Patient has no history of previous total hip replacement or arthrodesis of the affected hip joint(s). • Patient is willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Subjects will be excluded when they meet one or more of the following contra-indications for the SuperPath® technique: • Infection, sepsis, and osteomyelitis • Patients with a low femoral offset • Uncooperative patient or patient with neurologic disorders who are incapable of following directions • Insufficient bone stock to provide adequate support and/or fixation to the prosthesis • Metabolic disorders which may impair bone formation • Osteomalacia • Distant foci of infections which may spread to the implant site • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram • Vascular insufficiency, muscular atrophy, neuromuscular disease Additionally, subjects will be excluded when they meet the following exlusion criteria: • Patients with emergency or semi-emergency THA (e.g. for treatment of femoral neck fractures) • Patient has a known or suspected sensitivity or allergy to one or more of the implant materials • Revision THA surgery of the ipsilateral side • Contralateral THA <6 months before current surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility will evaluated by the length of the operation, placement of the implants and blood loss during the individual procedure. 2 of the 3 criteria must be met, in order to consider the surgery successful. Furthermore, if in 80% or more of the surgeries intra-operative complications (lesion of the n. Ischiadicus or a fissura of the femur) occur, the SuperPath procedure is not feasible. -Surgery time for a primary total hip arthroplasty using SuperPath® may not exceed 2.5 hours. -For the acetabular implant 20 to 60 degrees of inclination and 15 degrees of anteversion is accepted. The femoral implant should be placed straight in the femoral shaft and the hip rotation center should be restored anatomically -The average amount of bloodloss performing total hip arthroplasty with SuperPath® may not exceed 1000 cc. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the clinical results of performing SuperPath® and complications after surgery. Clinical results will be measured using the HHS, HOOS-PS, EQ5-D and OHS whilst radiographic outcomes will be evaluated through standard radiographic parameters. | — |
Contacts
Public ContactNina Mathijssen
Reinier de Graaf Groep
Outcome results
None listed