This study intends to evaluate early clinical outcomes and survivorship of the G7 Acetabular System. Ease of instrument use will also be documented.The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Harris Hip Score (HHS) at 2 year postoperative
Secondary outcome
Oxford Hip Score at 1,2,5 year postop
Radiographic Evaluation: radiographic outcome, stability, incidence of
radiolucencies around the prosthesis and bone remodeling
Adverse Events/Complications (including revisions/removals of the study hip).
Survivorship
Background summary
The always pressing need to provide more surgical options for the treatment of
patients needing total hip arthroplasty, while concurrently simplifying the
surgical process with well-designed modular components and corresponding
instruments, has led to the development of the Biomet G7* Acetabular Cup System.
The intended application is for the system to be used in conjunction with the
femoral components of a total hip arthroplasty system to reduce hip pain and
increase hip function.
Study objective
This study intends to evaluate early clinical outcomes and survivorship of the
G7 Acetabular System. Ease of instrument use will also be documented.
The primary purpose of this study is to evaluate the clinical and radiographic
performance of the G7 Acetabular Cup System in both primary and revision
procedures, report safety and survivorship, and document instrument ease of
use.
Study design
This is a global, multicenter, interventional study using three study
subgroups, with each of the subgroups including a different articulation of the
G7 cup. Patients who already have received the G7 cup, as well as patients who
will receive the G7 cup, will be asked to participate.
Subgroup 1
G7 cup with Metal on Polyethylene articulation (MOP)
105 cases
Subgroup 2
G7 cup with Ceramic on Polyethylene articulation (COP)
105 cases
Subgroup 3
G7 cup with Ceramic on Ceramic articulation (COC)
105 cases
Intervention
The use of a G7 cup in total hip replacement.
Study burden and risks
No additional risk or burden for the patient. This study is observational.
Toermalijnring 600
Dordrecht 3316 LC
NL
Toermalijnring 600
Dordrecht 3316 LC
NL
Listed location countries
Age
Inclusion criteria
Selection of subjects for this evaluation should be in accordance with the
indications of the G7 cup specifically:
Subjects with one of the following indication:
- Noninflammatory degenerative joint disease including osteoarthritis and
avascular necrosis.
- 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.
- Revision procedures where other treatment or devices have failed.
Additional inclusion criteria include:
- Male or female.
- 18 years of age or older
- Subjects willing to return for follow-up evaluations.
Exclusion criteria
Exclusion criteria should be in accordance with Contraindications for the G7
cup.
Absolute contraindications include: infection, sepsis and osteomyelitis,
Additional contraindications include:
- Subjects unable to cooperate with and complete the study
- Dementia and inability to understand and follow instructions
- Neurological conditions affecting movement
- Pregnancy
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46033.098.13 |