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van CCT (UK)

van CCT (UK)

Total hip replacement anterior versus lateral approach.

- candidate number9407
- NTR NumberNTR2882
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2011
- Secondary IDsM010-072 METC Westfriesgasthuis
- Public TitleTotal hip replacement anterior versus lateral approach.
- Scientific TitleResults of a total hip arthroplasty after anterior supine intermuscular or a transgluteal approach; a prospective study.
- hypothesisWe expect a higher functional level (Harris hip score) 6 weeks and one year after total hip replacement.
- Healt Condition(s) or Problem(s) studiedTotal hip replacement, Anterior supine intermuscular (ASI) approach, Transgluteal approach
- Inclusion criteria1. Indication for total hip arthroplasty;
2. BMI< 30 kg/m2;
3. Candidates for both approaches;
4. Candidates for uncemented prothesis (age < 70 year).
- Exclusion criteria1. Previous surgery on the affected hip prothesis of the ipsilateral hip;
2. Inflammatory polyarthritis;
3. Candidates for cemented prothesis (>70 year).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate1-sep-2012
- Target number of participants120
- InterventionsTotal hip arthroplasty trough an anterior superior intermuscular approach or a transgluteal approach. In each procedure, the same prothesis is placed. The benefits of the anterior superior approach are that a smaller incision will be made, patients will experience less pain, there will be a smaller amount of blood loss and less damage is done to the soft tissue so that patients will recover faster. Negative point is the risk of nerve damage. Benefit of the lateral approach is that the experience is high.
- Primary outcomeLevel of function (Harris hip score).
- Secondary outcome1. Dutch WOMAC-score;
2. SUSHI-score;
3. VAS complications;
4. Surgery-time;
5. Blood loss;
6. Length incision;
7. Days of hospital stay;
8. Range of motion.
- TimepointsAfter 3 days, 6 weeks, 3 and 6 months and 1 year
- Trial web siteN/A
- statusplanned
- CONTACT for SCIENTIFIC QUERIES Annelies Bemmel, van
- Sponsor/Initiator Westfriesgasthuis Hoorn
- Funding
(Source(s) of Monetary or Material Support)
Westfriesgasthuis Hoorn
- PublicationsN/A
- Brief summaryThe anterior supine intermuscular approach is a truly muscle-sparing approach to total hip arthroplasty with a low complication rate. The advantages include improved early recovery and return to everyday activities. Study-aim is to compare the level of function of primary total hip arthroplasties performed through an anterior and a transgluteal approach. Primary outcome is level of function (Harris hip score. Secondary outcomes are: Dutch WOMAC-score, SUSHI-score, VAS, complications, surgery-time, blood loss, length incision, days of hospital stay and range of motion.
- Main changes (audit trail)
- RECORD2-mei-2011 - 18-mei-2011

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