The primary objective is the investigation early migration of the SL-PLUS stem measured by means of Roentgen Stereophotogrammetric Analysis (RSA). Migration is assessed with regard to translation (x, y and z direction) and rotation.…
ID
Bron
Aandoening
hip, prosthesis, stability, Roentgen Stereophotogrammetric Analysis (RSA), stem
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
RSA migration during the first 5 years of follow up
Achtergrond van het onderzoek
An ongoing discussion is whether using a hydroxy-apatite coating enhances the ingrowth and longevity of a femoral stem in total hip arthroplasty. The best way to predict speed of ingrowth and long-term outcome is by performing a radiostereometric analysis study. In order to study the effect of hydroxyapatite (HA) coating on the migration of the SL-PLUS hip stem, a single center RSA, prospective double blind randomized controlled trial is being conducted. The primary objective is to investigate the early migration of the hydroxyapatite (HA)-coated SL-PLUS stem compared to the Standard (non-coated) SL-PLUS stem by means of RSA.
Doel van het onderzoek
The primary objective is the investigation early migration of the SL-PLUS stem measured by means of Roentgen Stereophotogrammetric Analysis (RSA). Migration is assessed with regard to translation (x, y and z direction) and rotation. Early migration will be compared between the HA-coated SL-PLUS stem (Study group) and the standard SL-PLUS stem (control group).
H0: Total migration in the HA-coated group is equal or more compared to the migration in the non-HA coated group.
H1: Total migration in the HA-coated group is less than in the non-HA-group.
Onderzoeksopzet
Pre-operative, direct postoperative, 6 weeks, 3 months, 6 months, 12 months, 2 years and 5 years.
Onderzoeksproduct en/of interventie
Total hip arthroplasty with either a standard or a hydroxyapatite coated stem.
Algemeen / deelnemers
Louwesweg 6<br>
Postbus 9440
D. Haverkamp
Amsterdam 1006 BK
The Netherlands
daniel.haverkamp@slz.nl
Wetenschappers
Louwesweg 6<br>
Postbus 9440
D. Haverkamp
Amsterdam 1006 BK
The Netherlands
daniel.haverkamp@slz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients with primary osteoarthritis, avascular necrosis, femoral neck fracture, or hip dysplasia
- Patients requiring primary arthroplasty
- Age at time of surgery: 60-75
- Both male and female
- Patients capable of giving informed consent and expressing a willingness to comply with the post-operative review program
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Post-traumatic OA (proximal femur fracture)
- Post-infection in respective joint
- Prior osteotomy of the affected hip
- Patients under treatment for osteoporosis (with bisphosphonate)
- OA patients diagnosed Charnley C
- Patients requiring cortisone medication
- Patients whose body mass index is higher than 35
- Patients already participating in the RSA hip study.
- The individual is unable or unwilling to sign the patient informed consent specific to this study
- Patients requiring revision arthroplasty
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5605 |
| NTR-old | NTR5844 |
| CCMO | NL23524.048.08 |
| OMON | NL-OMON32075 |