First metatarsophalangeal joint arthrodesis vs implant arthroplasty; Prospective randomised clinical trial.

First metatarsophalangeal joint arthrodesis vs implant arthroplasty; Prospective randomised clinical trial. - DART

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39417

Enrollment

Registered

2008-12-23

Start date

2009-07-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

hallux limitus hallux rigidus osteoartritis of the first metatarsophalangeal joint

Interventions

1. Arthrodesis of the MTPI joint. or 2. Implantation of a MTPI prosthesis.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: MTPI degenerative arthritis stage II or III

Exclusion criteria

Exclusion criteria: Diabetes neurogenic disorders age above 70 years

Design outcomes

Primary

Measure	Time frame
* AOFAS-HMI score * VAS pain score * Satisfaction score	—

Secondary

Measure	Time frame
* X-ray evaluatie ( anterior-posterior en lateraal) o DMAA angle o IMA angle o lengte eerste metatarsaal o Fusie in de arthrodesis groep o Positie van hardware in de prothese groep * SF-12 (dutch validated) quality of life score * Gait analysis (Dynaport® device) * voetdrukmeting (footscan® USB plate by RS International®) * Lichamelijk onderzoek o Range of motion van IP een MTPI o Stbiliteit van gewricht	—

Measure

Time frame

* X-ray evaluatie ( anterior-posterior en lateraal) o DMAA angle o IMA angle o lengte eerste metatarsaal o Fusie in de arthrodesis groep o Positie van hardware in de prothese groep * SF-12 (dutch validated) quality of life score * Gait analysis (Dynaport® device) * voetdrukmeting (footscan® USB plate by RS International®) * Lichamelijk onderzoek o Range of motion van IP een MTPI o Stbiliteit van gewricht

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)