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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29606

Enrollment

Registered

2015-02-25

Start date

2014-03-25

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

- RSA analysis, implantation of tantalum beads

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
- RSA analysis in terms of micromotion, loosening and subsidence.	—

Secondary

Measure	Time frame
- clinical outcome - subjective outcome - complications	—

Contacts

Public ContactB.J.W. Thomassen

Haaglanden Medical Center PO Box 432

b.thomassen@mchaaglanden.nl+31 (0)70 3303109

Outcome results