Since 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.
ID
Bron
Verkorte titel
Aandoening
Osteoarthritis of the hip
avascular femoral head necrosis
coxarthrose
heup arthose
femurkop necrose
Ondersteuning
Oosterpark 9
Postbus 95500
1090 HM Amsterdam
telephone: 0031-(0)20-5999111
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- The Dutch and the German version of the Hip disability and Osteoarthritis Outcome Score (HOOS).
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
Since 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.
Onderzoeksopzet
• 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.
Onderzoeksproduct en/of interventie
Curved Stemmed Total Hip Arthroplasty:
CFP Stem
Uncemented Straight Stemmed Total Hip Arthroplasty
Publiek
Postbus 95500
R.W. Poolman
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
+31 (0)20 5999111
namloop@gmail.com
Wetenschappelijk
Postbus 95500
R.W. Poolman
Oosterpark 9
Amsterdam 1090 HM
The Netherlands
+31 (0)20 5999111
namloop@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1489 |
| NTR-old | NTR1560 |
| Ander register | : R-08.18O/CUSTOM |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |