The objectives of this prospective clinical study are:1. Obtain multi-center, long-term (10-year) clinical data on the new GTS® femoral stem inits standard and lateralized versions2. Collect quality of life data
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean Harris Hip Score (HHS) at 2 years postoperative
Secondary outcome
-Radiographic evaluation: stability, incidence of radiolucencies around the
prosthesis and
bone remodeling
- Patient satisfaction: EQ5D quality of life
- Adverse Events/Complications (including revisions/removals).
- Survivorship
Background summary
The Global Tissue Sparing (GTS) stem designed by Biomet in collaboration with
Dr Grappiolo,
is a new cementless stem, based on the Spotorno CLS stem design.
Dr Grappiolo carried out a study on morphology and as a result of anatomic
analysis concluded
that it was vital for a stem to fulfill varus and valgus needs from a standard
stem. As a result of
this study, he initiated the CLS change to 125°. This provided a more flexible
system with the
practical applications for covering all morph types.
Study objective
The objectives of this prospective clinical study are:
1. Obtain multi-center, long-term (10-year) clinical data on the new GTS®
femoral stem in
its standard and lateralized versions
2. Collect quality of life data
Study design
An international multi centre, prospective, non controlled study, involving 250
patients distributed between GTS standard and lateralized groups.
Study burden and risks
None
Toermalijnring 600
Dordrecht 3316LC
NL
Toermalijnring 600
Dordrecht 3316LC
NL
Listed location countries
Age
Inclusion criteria
1. Male and non-pregnant females : >= 18 years and <= 70 years
2. Patients requiring primary THR, suitable for the use of the GTS stem.
3. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis.
4. The individual is physically and mentally willing and able to comply with
postoperative functional evaluation and able to participate in an appropriate
rehabilitation schedule.
5. ASA classification score I-III.
6. Patients who signed the Ethics Committee approved specific Informed Consent
Form prior to surgery.
7. Surgical technique is planned to be Anterior Supine Intramuscular (ASI), or
patient has already received a GTS hip on the contralateral side.
Exclusion criteria
1. Patients who had a THA on contralateral side more than 6 months ago and the
rehabilitation period outcome is considered unsatisfactory or not good.
(Patients with contra-lateral THA >6 months ago with good outcome (Harris Hip
Score >85) can be included in the study).
2. Patients who had a THA on contralateral side less than 6 months ago.
3. Patients with a major surgical procedure during the 12 weeks before the
study-related
operation.
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | NCT02851992 |
| CCMO | NL48747.098.14 |