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Minimally invasive surgery in total hip arthroplasty: the 2-incision technique vs convemtional total hip arthroplasty. A prospective, randomised, controlled trial.


- candidate number1819
- NTR NumberNTR500
- ISRCTNISRCTN77525474
- Date ISRCTN created9-jan-2006
- date ISRCTN requested13-dec-2005
- Date Registered NTR7-nov-2005
- Secondary IDsN/A 
- Public TitleMinimally invasive surgery in total hip arthroplasty: the 2-incision technique vs convemtional total hip arthroplasty. A prospective, randomised, controlled trial.
- Scientific TitleMinimally invasive surgery in total hip arthroplasty: the 2-incision technique vs convemtional total hip arthroplasty. A prospective, randomised, controlled trial.
- ACRONYMN/A
- hypothesisanatomy sparing 2-incision total hip arthroplasty (THA) has a better functional outcome than conventional THA.
- Healt Condition(s) or Problem(s) studiedArthritis, Total hip replacement (THR)
- Inclusion criteria1. Male or female being 18 years or older;
2. Patients meet the criteria for osteoarthritis:
a. Pain in hip;
b. Arthritic changes on radiograph:
joint space narrowing femoral / acetabular osteofytes;
3. Patients not responding to conservative therapy;
4. Written informed consent for study participation.
- Exclusion criteria1. Patients who are mentally impaired and not able to fill in questionnaires;
2. Patients who do not know the Dutch language;
3. Patients with a BMI of more than 40;
4. Patients with skeletal immaturity;
5. Patients with a life expectancy of less than 3 years;
6. Patients with altered anatomy resulting in impossibility for the MIS procedure, according to the surgeon e.g.:
a. Hip dysplasia with high luxation
b. Post traumatic severe anatomy change
c. Post correction osteotomy;
7. Patients with extremity amputation;
8. Patients with an active malignant disease or current cytostatic treatment;
9. Patients who are participating in another trial;
10. Known alcohol or drug abuse.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-nov-2005
- planned closingdate1-jan-2009
- Target number of participants110
- InterventionsTotal hip arthroplasty: conventional lateral approach or 2-incision anatomy sparing approach.
- Primary outcomeThe purpose of the study is to scientifically determine the functional effectiveness of anatomy sparing surgery in total hip arthroplasty in comparison with traditional open surgery, measured by the Harris Hip Score.
- Secondary outcomeNumber of virtual admission days. Virtual is defined as the number of days until the patient is ready for discharge in the opinion of the surgeon and the patient. Any additional days due to logistic circumstances are not included in this main objective.
Virtual discharge criteria are: -function, measured in: -50m walking, -walking 1 stairs, -getting in and out of bed-Pain (VAS icm function)-Wound assessment: incl. effusion + aspect
-The Western Ontario and McMaster Universities Osteoarthritis Index
-Visual Analogue Scale (VAS) is used to measure severity of pain during different activities. (Corianne kijkt hoe pijnmedicatie en VAS-score te combineren) Use of analgesics.
-The SF-36 (pre-operative and at 1 year follow-up)
-Patient satisfaction (Corianne: zijn verschillende mogelijkheden)
-Total operation time.
-Number and kind of complications (incl wound infection, wound haematoma, dislocations (main objective gebaseerd op funtionele uitkomst, compl dus geen effect!)
-Need for blood transfusion.
-Wound aspect during treatment period.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. M.J.J. Veth
- CONTACT for SCIENTIFIC QUERIESDr. M.U. Schafroth
- Sponsor/Initiator Zimmer
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD7-nov-2005 - 6-mrt-2006


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