To perform a comparative assessment between the clinical and radiographic outcomes (as measured with RSA) of the conventional GTS stem compared to the Taperloc stem in patients undergoing primary uncemented THA over a period of 10 years (primary…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is stem migration at 2 years postoperatively measured with
RSA analysis.
Secondary outcome
Outcome will be clinically measured using the Harris Hip Score (HHS), HOOS
(WOMAC) questionnaire, EQ5-D, whilst radiographic outcomes will be evaluated
through standard radiographic parameters which include qualitative femoral and
acetabular findings as well as position of the stem and cup. RSA will be used
to measure stem migration.
Background summary
The use of a stem in total hip arthroplasty is important to resist varus/valgus
stress, but a trend is seen that the stems become shorter. The trend is that
the stems are as short as possible and with flexibility as close as possible to
that of the femur to decrease the compressive stresses to the lateral femoral
cortex. The concept of the GTS hip is based on the successful design of the CLS
Spotorno hip. The GTS stem incorporates new features to address the growing
demand for bone conserving, tissue sparing total hip arthroplasty. The
objective of bone preservation is attained through preservation of the greater
trochanter and limited invasion of the femoral canal. The GTS has a reduced
lateral shoulder making the implantation easier without compromising the
stability.
Press-fit ensures primary stability of cement-less components. The implant
stability of the GTS stem is achieved in 3 different ways. Firstly, metaphyseal
press-fit obtained by the tapered wedge design and femoral bone compaction.
Secondly, rotational stability thanks to
the elliptic-octagonal stem cross-section. Thirdly, enhanced rotational
stability achieved by the longitudinal anterior and posterior bone compression
fins.
Study objective
To perform a comparative assessment between the clinical and radiographic
outcomes (as measured with RSA) of the conventional GTS stem compared to the
Taperloc stem in patients undergoing primary uncemented THA over a period of 10
years (primary objective is stability over 2 years).
Study design
A prospective randomised clinical trial in which 50 cases (25 vs. 25) will be
enrolled over two hospitals. The primary components to be implanted are an
uncemented GTS stem and a Taperloc stem both combined with the uncemented
Regenerex cup. All patients will have a 32 mm head and will be operated with
the ASI technique. Patients will be evaluated preoperatively and
postoperatively at discharge (from operation date to date of discharge) at, 3
months, 6 months,1 year, 2 years, 5 years and 10 years.
Study burden and risks
Subjects participating in the study have the same risks and benefits when not
participating in the study. The new component used in the study is based on
designs already in use. The Taperloc is clinically successfully used for thirty
years. Follow-up times are standard protocol evaluations of prosthesis. Besides
standard radiological followup, RSA x-rays will be made to measure the
fixation of the stem.
Bronovolaan 5
Den Haag 2597 AX
NL
Bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
- Male and non-pregnant females : <= 70 years
- Patients with a Quetelet index (QI=weight in (kilogram)/ square length
(meters)) < 35.
- Patients requiring primary THR, suitable for the use of the GTS and Taperloc
stem.
- The patient is diagnosed with osteoarthritis (OA) or avascular necrosis.
- ASA classification score I-III.
Exclusion criteria
- 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).
- Patients who had a THA on contralateral side less than 6 months ago.
- Patients with a major surgical procedure during the 12 weeks before the
study-related operation.
- Dutch language not mastered
- The patient is unwilling to cooperate with the study
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL40704.098.12 |
| Other | NTR TC-3564 |