|- candidate number||27323|
|- NTR Number||NTR6468|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mei-2017|
|- Secondary IDs||17-060 METC Zuidwest Holland |
|- Public Title||Fixation and migration of the G7 BiSpherical acetabular system combined with the GTS stem for total hip arthroplasty - an RSA study|
|- Scientific Title||Fixation and migration of the G7 BiSpherical acetabular system combined with the GTS stem for total hip arthroplasty - an RSA study|
|- ACRONYM||G7-GTS RSA|
|- hypothesis||The G7 BiSpherical acetabular system and the GTS femoral stem will have acceptable migration patterns at the two-year follow-up mark (G7 BiSpherical acetabular system) and at six months (GTS femoral stem)|
|- Healt Condition(s) or Problem(s) studied||Hip, Prosthesis, Arthroplasty , Unicondylar, Radio Stereometric Analysis|
|- 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 G7BiSpherical cup and GTS stem, subjects in this study must have a primary diagnosis of noninflammatory degenerative joint disease. Additional indications may be present)
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 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 Exclusion criteria)
Subjects must additionally meet the following criteria to participate in this study:
Age >18 years and < 75 years
Patient is willing to participate
Patient is able to speak and write Dutch
Patient qualifies for THA with the G7 BiSpherical cup and GTS stem based on physical exam and medical history
Patient is able and willing to provide written informed consent
|- 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
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
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2017|
|- planned closingdate||1-jul-2023|
|- Target number of participants||25|
|- Interventions||Placement of the G7 BiSpherical acetabular system and the Global Tissue Sparing (GTS) femoral stem, with insertion of tantalum beads for radiostereophotogrammetric analysis(RSA)|
|- Primary outcome||Fixation and migration patterns of the G7 acetabular system and GTS femoral stem in vivo, using model-based RSA.|
|- Secondary outcome||Short- and midterm clinical results by means of:|
Numeric Rating Scale (NRS) for pain
Range of Motion (ROM)
Hip injury and Osteoarthritis Outcome Score (HOOS-PS)
Oxford Hip Score (OHS)
|- Timepoints|| Pre-operative|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| N.M.C. Mathijssen|
|- CONTACT for SCIENTIFIC QUERIES|| N.M.C. Mathijssen|
|- Sponsor/Initiator ||Department of Orthopaedics, Reinier de Graaf Groep|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Cementless total hip arthroplasty (THA) has very good clinical results. As a result of the success, the ageing population and because the procedure is performed in increasingly younger and more active patients, the number of THA procedures has increased the last decades. After failure of a primary THA, a more challenging and costly hip revision surgery is needed, mainly due to management of the bone stock loss. Therefore, the new shorter GTS stem was developed to prevent the loss of bone stock. |
Nowadays the risk of poor performing survival over time should be limited. The only clinical test that can provide data to predict long survival is stability testing with RSA. As a result, the risk of implanting potentially inferior prostheses in patients will be reduced, resulting in less suffering for patients and a reduction in healthcare expenses.
This study identifies the radiographic outcomes, implant survival, fixation and migration patterns of the G7 BiSpherical acetabular system combined with the GTS stem, up to five years after implantation.
Objective: Identifying the fixation and migration patterns of the G7 BiSpherical acetabular system combined with the GTS stem (Zimmer Biomet) prosthesis in vivo, using model based roentgen radiostereophotogrammetric (mRSA) analysis over a period of 5 years.
Study design: A prospective clinical trial in which 25 cases will be enrolled over one hospital. Patients will be evaluated preoperatively and postoperatively at discharge (from operation date to date of discharge), at 6 weeks, 6 months, 1 year, 2 years and 5 years.
Study population: The study population consists of active male or non-pregnant female 18-75 years of age. The subjects have no clinical relevant disorders of the hip and they will undergo a hip arthroplasty with the G7 BiSpherical acetabular system combined with the GTS stem, after diagnosis of osteoarthritis.
Intervention (if applicable): Placement of the G7 BiSpherical acetabular system combined with the GTS stem.
Main study parameters/endpoints: Outcome will be clinically measured using the HOOS-PS, EQ5-D and OHS whilst radiographic outcomes will be evaluated through standard radiographic parameters. RSA will be used to measure migration of the prosthesis.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects participating in the study have the same risks and benefits when not participating in the study. All components used in the study have CE mark and are already in use. Besides standard radiological follow-up, RSA x-rays will be made to measure the fixation of the prosthesis.
|- Main changes (audit trail)|
|- RECORD||26-mei-2017 - 3-jul-2017|