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BIOPRO resurfacing endoprosthesis versus Keller resection arthroplasty for symptomatic hallux rigidus patients

BIOPRO resurfacing endoprosthesis versus Keller resection arthroplasty for symptomatic hallux rigidus patients - BIOPRO hemi prosthesis for hallux rigidus patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30275
Enrollment
60
Registered
2009-05-15
Start date
2007-02-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

hallux limitus osteoartritis of the big toe

Interventions

Operative treatment with either a BIOPRO® hemi prosthesis or a Keller resection arthroplasty.

Sponsors

Maaslandziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) hallux rigidus 2) painful FMTP joint

Exclusion criteria

Exclusion criteria: 1) hallux valgus or hallux valgus et rigidus 2) patients suffering rheumatoid arthritis 3) (previous) FMTP joint infection 4) severe neurovascular compromised patients 5) metatarsalgia

Design outcomes

Primary

MeasureTime frame
Patient satisfaction, pain, function, AOFAS score, FAOS questionnaire, radiographic evaluation, complications.

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)