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Clinical Trials/ACTRN12610000855022
ACTRN12610000855022
Withdrawn
未知

Patients with non-inflammatory osteoarthritis requiring a partial knee replacement will have tantalum beads inserted at the time of surgery in order to reference implant movement over time and these results will be compared with results from the literature of others with partial knee replacements.

De Puy International0 sites25 target enrollmentOctober 14, 2010

Overview

Phase
未知
Intervention
Not specified
Conditions
on-inflammatory osteoarthritis of the knee
Sponsor
De Puy International
Enrollment
25
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 14, 2010
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
De Puy International

Eligibility Criteria

Inclusion Criteria

  • 1\. Consent
  • 2\. Non\-inflammatory osteoarthritis of the medial
  • compartment of the knee
  • 3\. A mechanical axis deformity less than 10degrees varus
  • or 5 degrees valgus
  • 4\. An intact anterior cruciate ligament without medial\-lateral
  • subluxation
  • 5\. A flexion contracture less than 10degrees
  • 6\. Body weight less than 90kg

Exclusion Criteria

  • 1\. Patients with active infection
  • 2\. Patients requiring total knee replacement surgery
  • 3\. Patients requiring revision surgery of a previously implanted unicompartmental knee
  • 4\. Patients with presence of malignancy in the area of the involved knee joint
  • 5\. Patients who, as judged by the surgeon, are mentally incompetent or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow\-up evaluation schedule
  • 6\. Patients with a physical condition (ie. weight exceeding 90kgs) or a neuromuscular deficit which interferes with the patient's ability to limit weight\-bearing or places an extreme load on the implant during the healing period
  • 7\. Patients with other concurrent illnesses that are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis

Outcomes

Primary Outcomes

Not specified

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