Arthrodesis versus endoprosthesis - a prospective randomized trial for Hallux rigidus

Not Applicable

• Conditions: M20.2; Hallux rigidus

• Registration Number: DRKS00000133
• Lead Sponsor: Orthopädische Universitätsklinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. male or female, 30 through 75 years
2. patients with arthrosis of the big toe base joint in stage 2 to 4
3. patients with 30 minutes stretch of way
4. the qualified patient approves the attendance to the study by signing the dated declaration of consent
5. the patient stands by for a follow up at least one year
6. the patient is in a stable state of health having or is concerned with no diseases (cardial, pulmonal, hemic diseases or others), that would be a unacceptable high risk regarding the operation.

Exclusion Criteria

1. patients with deficient known bone substance by diseases like chancer, osteotomy in os metatarsale or the proximal phalanx or diseases with metabolic disorder that lead to tissue calcification.
patients in certain physical condition like pathological overweight (BMI > 30).
2. patients with active local or systemic infections
3. patients that were operated at the same location before
4. immunodeficiency - immune defects are chronic conditions that obviously reduce the patients ability to react on antigen stimulation. for example patients that are treated by immunosuppressive drugs (high dosed corticosteroids, cytostatic agents, high doses of anti lymphocyte serum or radiation) are afflicted with immunodeficiency, also patients that are immune suppressed to avoid rejection reaction against homologous transplants, and also patients with acquired immune deficiency syndrom (AIDS) or autoimmune diseases (except rheumatoid arthritis).
5. Pregnancy (exclusion by anamnesis or if necessary by pregnancy test).
6. Patients that take part at other clinical studies testing pharmaceuticals, biological substances or medicine devices.
7. Patients whose hallux-angle amounts > 25 °.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual analogue scale of post-operative pain with a questionnaire 1 year postoperatively