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Clinical Trials/NCT02625311
NCT02625311
Completed
Phase 4

A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty

Maastricht University Medical Center0 sites69 target enrollmentDecember 2004
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ConditionsOsteoarthritis, Knee

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Maastricht University Medical Center
Enrollment
69
Primary Endpoint
blood loss
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis.

Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.

Detailed Description

Study executed with 3 centers and 69 patients.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
January 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •patient requiring Total Knee Arthroplasty (TKA)
  • •patients with Osteo arthritis
  • •intact collateral ligaments and patella tendon
  • •patients willing and able to comply with the post-operative schedule

Exclusion Criteria

  • •patients who require a revision TKA
  • •patients with TKA contralateral knee within 6 months with bad outcomes
  • •patients who need a TKA on contralateral side within 2 years
  • •intraoperative resurfacing of patella
  • •intraoperative eversion of patella
  • •patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy
  • •BMI \> 30
  • •patients with fixed flexion contracture\> 15 degrees
  • •patients with deformity greater than 20 degrees of varus or 15 degrees of valgus
  • •Patient with Mediolateral stability \> 10 degrees patient with active or suspected malignancy

Outcomes

Primary Outcomes

blood loss

Time Frame: 24 hours after surgery

measurement of milliliters blood loss during the first 24 hours after surgery

range of motion

Time Frame: pre-op vs post-op until 5 years post-op

measurement of flexion and extension in degrees

Secondary Outcomes

  • chair rise and stair climb test(pre-op vs post-op until 5 years post operative)
  • patient questionnaire(pre-op vs post-op until 5 year post operative)

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