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 10 years.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
N/A
Background summary
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 ten years after implantation.
Study 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 10 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, 5 years and 10 years.
Intervention
Placement of the G7 BiSpherical acetabular system combined with the GTS stem.
Study burden and risks
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.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
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 <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
• 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
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL61271.098.17 |
| OMON | NL-OMON24421 |