hip prosthesis Hip wear/osteoarthritis
Conditions
Interventions
Placement of the G7 BiSpherical acetabular system combined with the GTS stem.
Sponsors
Reinier Haga Orthopedisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The G7 BiSpherical cup and GTS stem are intended for patients with the following indications for THA: • Noninflammatory degenerative joint disease (e.g. OA, avascular necrosis) (although there are more indications for the G7 BiSpherical cup and GTS stem, subjects in this study must have a primary diagnosis of noninflammatory degenerative joint disease. Additional indications may be present) • Rheumatoid arthritis • Correction of functional deformity • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques (Although this is an indication for the G7 BiSpherical cup as well as the GTS stem, only patients with primary, elective THA are included in this study. See *4.3 Exclusion criteria*) • Revision procedures where other treatment or devices have failed (Although this is an indication for the G7 BiSpherical cup, patients with previous ipsilateral THA will not be included in this study. See *4.3 Exclusion criteria*) Subjects must additionally meet the following criteria to participate in this study: • Age >18 years and
Exclusion criteria
Exclusion criteria: Subjects will be excluded when they meet one or more of the following contra-indications for the G7 BiSpherical cup and/or GTS stem: • Infection, sepsis, and osteomyelitis • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome will be clinically measured using the HOOS-PS, EQ5-D, OHS and NRS whilst radiographic outcomes will be evaluated through standard radiographic parameters. RSA will be used to measure migration of the prosthesis. | — |
Countries
Netherlands
Outcome results
None listed