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Curved versus Straight Stem Uncemented Total Hip Arthroplasty. Osteoarthritis Multicenter trial.


- candidate number4597
- NTR NumberNTR1560
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-nov-2008
- Secondary IDsR-08.18O/CUSTOM 
- Public TitleCurved versus Straight Stem Uncemented Total Hip Arthroplasty. Osteoarthritis Multicenter trial.
- Scientific TitleCu rved versus Straight Stem Uncemented Total Hip Arthroplasty. Osteoarthritis Multicenter trial.
- ACRONYMCUSTOM
- hypothesisSince the CFP stem preserves the insertion of the gluteus muscle on the greater trochanter we expect to find a better short term functional result after CFP stem THA compared to conventional straight stem THA as reflected in higher HOOS scores.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Hip diseases, Arthroplasty , Coxarthroses
- Inclusion criteriaPatients with disabling osteoarthritis of the hip who are not responding to conservative treatment for at least twelve months, who clinically fulfil the criteria to undergo a cementless total hip arthroplasty.
1. Male or female being 18 years or older
2. Patients meet the criteria for osteoarthritis:
-Pain in one hip
-Arthritic changes on radiograph: joint space narrowing, femoral / acetabular osteofytes, cysts and signs of sclerosis
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 out questionnaires
2. Patients who do not know the Dutch or English or German language
3. Patients with a BMI of more than 40
4. Patients with skeletal immaturity
5. Patients with a life expectancy of less than 5 years
6. Patients with altered anatomy resulting in impossibility for the CFP procedure, according to the surgeon e.g.:
-hip dysplasia with high luxation
-post traumatic severe anatomic change
-post-correction osteotomy
7. Patients with lower extremity amputation
8. Patients with an active malignant disease or current cytostatic treatment
9. Patients who are participating in another clinical trial
10. Known alcohol or drug abuse
11. Any condition that would impede measurement of efficacy to the opinion of the surgeon
12. Patients with a previous contralateral hip arthroplasty
13. Patients with contralateral hip pain
14. Avascular head necrosis due to sickelcel anemia
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2009
- planned closingdate1-jan-2016
- Target number of participants150
- InterventionsCurved Stemmed Total Hip Arthroplasty:
CFP Stem
Uncemented Straight Stemmed Total Hip Arthroplasty
- Primary outcome- The Dutch and the German version of the Hip disability and Osteoarthritis Outcome Score (HOOS).
- Secondary outcome* Composite outcome of re-operations or re-intervention
Including:
- Reduction of dislocation
- Irrigation and debridement for infection
- Open reduction of periprosthetic fractures
- Revision
- Bleeding / haematoma requiring surgical intervention
- Any other planed or unplanned surgical intervention regarding the allocated implant. * complications Including:
- Bleeding / vascular damage
- Neurogenic damage
- Fractures
- Dislocation
- Infection
- Loosening
- Deep venous thrombosis
* Pain on a numeric rating scale (NRS) 0-10. (23)
* The Short-Form (SF-36) 36 item questionnaire
* The Oxford Hip Score
* Position of the prosthesis:
Roentgen:
- Anterior Posterior pelvis roentgenogram with the feet in neutral alignment
- With Zweymuller stems the holes in the trochanteric region need to be round in all x-rays.
- X-hip faux profile
- Timepoints 2 weeks
6 weeks
3 months (at home)
6 months (at home)
One year
Annually subsequent 4 years
This results in a total follow-up period of 5 years.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R.W. Poolman
- CONTACT for SCIENTIFIC QUERIESDr. R.W. Poolman
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
Stichting tot Bevordering van Deskundigheid in de Orthopaedie
- PublicationsN?A
- Brief summaryThe purpose of the study is to compare the functional result of CFP stem THA with conventional uncemented straight stem THA, measured by the Dutch or German version of the Hip disability and Osteoarthritis Outcome Score (HOOS) at three months follow-up. The secondary objective will be an evaluation of secondary outcomes. A prospective patient blinded randomized controlled multicentre study.
Straight stemmed total hip arthroplasty involves the insertion of a cementless stem parallel to the longitudinal axis of the femur. Anchorage is on the lateral metaphysic and / or on the diaphysis of the femur. The most commonly used straight stem is the Alloclassic also known as Zweymuller stem (Zimmer, USA). Curved stemmed total hip arthroplasty involves the use of the Collum Femoris Preserving stem (Waldemar Link, Germany). A T.O.P. uncemented acetabular cup (Waldemar Link, Germany) with a polyethylene liner will be used as acetabular component in all cases. Patients will be blinded for the type of prosthesis for the duration of 5 years.
- Main changes (audit trail)
- RECORD25-nov-2008 - 2-dec-2008


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