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Comparative roentgen stereophotogrammetry analysis of the Global Tissue Sparing (GTS) stemŪ compared with uncemented HA coated Taperloc stem.


- candidate number13212
- NTR NumberNTR3564
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-aug-2012
- Secondary IDs12-080 METC MC Haaglanden
- Public TitleComparative roentgen stereophotogrammetry analysis of the Global Tissue Sparing (GTS) stemŪ compared with uncemented HA coated Taperloc stem.
- Scientific TitleComparative roentgen stereophotogrammetry analysis of the Global Tissue Sparing (GTS) stemŪ compared with uncemented HA coated Taperloc stem.
- ACRONYMRSA analysis of GTS vs Taperloc stem
- hypothesisThe implant stability for the GTS is equal to the Taperloc in the initial two years and also thereafter. Focus will be on proximal or distal migration of the centre of the stem, migration of the tip, wear and survival.
- Healt Condition(s) or Problem(s) studiedArthroplasty , Hip, Radio Stereometric Analysis
- Inclusion criteria1. Male and non-pregnant females : ≤ 70 years;
2. Patients with a Quetelet index (QI=weight in (kilogram)/ square length (meters)) < 35;
3. Patients requiring primary THR, suitable for the use of the GTS and Taperloc stem;
4. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis;
5. The individual is physically and mentally willing and able to comply with postoperative functional evaluation and able to participate in an appropriate rehabilitation schedule;
6. ASA classification score I-III;
7. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.
- Exclusion criteria1. 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;
4. Dutch language not mastered;
5. The patient is unwilling to cooperate with the study;
6. The patient is pregnant or desired to be pregnant after surgery or is using inadequate birth control;
7. Recent Myocardial infarct or CVA (<3 months).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate1-jun-2024
- Target number of participants50
- InterventionsPlacement of an uncemented GTSŪ or uncemented porous coated TaperlocŪ stem in combination with an uncemented Regenerex and E1 liner.
- Primary outcomeStem migration measured with RSA analysis.
- Secondary outcomeClinical outcome:
1. Harris Hip Score (HHS);
2. HOOS questionnaire;
3. EQ5-D;
4. Standard radiographic parameters which include qualitative femoral and acetabular findings.
- TimepointsBaseline, direct postoperative, 3 months, 6 months, 1 year, 2 years, 5 years, 10 years.
- Trial web sitewww.mchaaglanden.nl/orthopedie
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. B.J.W. Thomassen
- CONTACT for SCIENTIFIC QUERIESDrs. B.J.W. Thomassen
- Sponsor/Initiator Medical Center Haaglanden, Reinier de Graaf Groep, afdeling orthopedie
- Funding
(Source(s) of Monetary or Material Support)
Biomet GSCC
- PublicationsN/A
- Brief summaryRationale:
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.

Objective:
To perform a comparative assessment between the clinical, bone remodelling, 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). Bone remodelling and all complications will be documented.

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 population:
The study population consists of active male or non-pregnant female 18- 70 years of age, with a QI (BMI) <35. The subjects have no clinical relevant disorders of the hip and they undergo a primary total hip replacement, after diagnosis of osteoarthritis or avascular necrosis.

Intervention:
Placement of an uncemented GTSŪ or uncemented porous coated TaperlocŪ stem in combination with an uncemented Regenerex and E1 liner.

Main study parameters/endpoints:
Outcome will be clinically measured using the Harris Hip Score (HHS), HOOS 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.

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. 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 and DEXA will be made to measure the fixation of the stem.
- Main changes (audit trail)
- RECORD7-aug-2012 - 19-mei-2014


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