The aim of this pilot study is to demonstrate the biomechanical behavior of the BIOPRO MTP-1 prosthesis and to obtain the clinical precision of the RSA technique and model used.
ID
Bron
Verkorte titel
Aandoening
- roentgen stereophotogrammetry analysis
- MTP-1 hemiarthroplasty
- hallux rigidus
- migration
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- RSA analysis in terms of micromotion, loosening and subsidence.
Achtergrond van het onderzoek
Hallux rigidus is one of the most common foot problems encountered in orthopaedic practice, leading to pain and restricted foot and hallux motion. Depending on the stage of the disease the treatment is conservative or surgical. For advanced stages of hallux rigidus both arthrodesis and arthroplasty have been advised. Reports in literature up to 33 years of clinical follow up, about the outcome of arthroplasty with a metallic hemiprosthesis, e.g. BIOPRO MTP-1, have shown mixed results. Persisting pain in the first metatarsophalangeal joint due to loosening of the implant has been reported to be the main reason of disappointing outcome.
In Medisch Centrum Haaglanden both arthrodesis and arthroplasty are performed for advanced and end-stage hallux rigidus. For arthroplasty the BIOPRO MTP-1 metallic
hemiprosthesis is used. We are planning a pilot study to determine the subsidence and loosening of the prosthesis with RSA analysis and to correlate the radiological with the
clinical follow up.
Doel van het onderzoek
The aim of this pilot study is to demonstrate the biomechanical behavior of the BIOPRO
MTP-1 prosthesis and to obtain the clinical precision of the RSA technique and model used.
Onderzoeksopzet
preoperative
6 weeks
3 months
6 months
1 year
2 years
Onderzoeksproduct en/of interventie
- RSA analysis, implantation of tantalum beads
Publiek
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
Wetenschappelijk
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. All patients with advanced or end stage hallux rigidus with an indication for a MTP1-
hemiarthoplasty
2. Patients who signed the Ethics Committee approved specific Informed Consent Form
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Earlier surgery to the first ray
2. Cerebral palsy
3. Not motivated for inclusion
4. Pregnant patients
5. Prior inclusion in this study
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 | NL4963 |
| NTR-old | NTR5067 |
| Ander register | NL44485.098.13 : METC no. 13-052, MCH no. 2013-066 |