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Fixation and Migration of the BIOPRO Metallic MTP-1 hemiprosthesis analysed with roentgen stereophotogrammetry analysis: A pilot study


- candidate number21720
- NTR NumberNTR5067
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-feb-2015
- Secondary IDsMETC no. 13-052, MCH no. 2013-066 NL44485.098.13
- Public TitleFixation and Migration of the BIOPRO Metallic MTP-1 hemiprosthesis analysed with roentgen stereophotogrammetry analysis: A pilot study
- Scientific TitleFixation and Migration of the BIOPRO Metallic MTP-1 hemiprosthesis analysed with roentgen stereophotogrammetry analysis: A pilot study
- ACRONYMBIOPRO-RSA
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedRoentgen Stereophotogrammetric Analysis , MTP-1 hemiarthroplasty, Migration, Hallux rigidus
- Inclusion criteria1. 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 criteria1. Earlier surgery to the first ray
2. Cerebral palsy
3. Not motivated for inclusion
4. Pregnant patients
5. Prior inclusion in this study
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 25-mrt-2014
- planned closingdate
- Target number of participants10
- Interventions- RSA analysis, implantation of tantalum beads
- Primary outcome- RSA analysis in terms of micromotion, loosening and subsidence.
- Secondary outcome- clinical outcome
- subjective outcome
- complications
- Timepointspreoperative
6 weeks
3 months
6 months
1 year
2 years
- Trial web sitewww.mchaaglanden.nl/orthopedie
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. B.J.W. Thomassen
- CONTACT for SCIENTIFIC QUERIESDrs. B.J.W. Thomassen
- Sponsor/Initiator Medical Center Haaglanden
- Funding
(Source(s) of Monetary or Material Support)
MCH wetenschapsfonds
- Publications
- Brief summaryHallux 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.
- Main changes (audit trail)
- RECORD25-feb-2015 - 19-apr-2015


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