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Clinical Trials/ISRCTN10526056
ISRCTN10526056
Completed
Not Applicable

I-ONE therapy in patients undergoing total knee arthroplasty: Prospective and randomised study with a control group

IGEA (Italy)0 sites30 target enrollmentNovember 4, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee arthritis
Sponsor
IGEA (Italy)
Enrollment
30
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 4, 2010
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
IGEA (Italy)

Eligibility Criteria

Inclusion Criteria

  • 1\. Either sex, aged \= 60 and \< 85
  • 2\. Presenting an advanced state of knee arthritis and scheduled for prosthetic replacement
  • 3\. Misalignment in varus/valgus respectively not exceeding 20° and 15° and deformity in bending less than 15°

Exclusion Criteria

  • 1\. Patients who had undergone previous surgery to the same knee or had been operated on for hip prosthesis
  • 2\. Patients with BMI \>30 Kg/m2
  • 3\. Patients with pathological processes such as
  • 3\.1\. rheumatoid arthritis
  • 3\.2\. autoimmune conditions
  • 3\.3\. systemic diseases
  • 3\.4\. tumours

Outcomes

Primary Outcomes

Not specified

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