No registrations found.
ID
Source
Brief title
Health condition
- roentgen stereophotogrammetry analysis
- MTP-1 hemiarthroplasty
- hallux rigidus
- migration
Sponsors and support
Intervention
Outcome measures
Primary outcome
- RSA analysis in terms of micromotion, loosening and subsidence.
Secondary outcome
- clinical outcome
- subjective outcome
- complications
Background summary
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.
Study objective
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.
Study design
preoperative
6 weeks
3 months
6 months
1 year
2 years
Intervention
- RSA analysis, implantation of tantalum beads
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
Inclusion criteria
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
Exclusion criteria
1. Earlier surgery to the first ray
2. Cerebral palsy
3. Not motivated for inclusion
4. Pregnant patients
5. Prior inclusion in this study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4963 |
| NTR-old | NTR5067 |
| Other | NL44485.098.13 : METC no. 13-052, MCH no. 2013-066 |