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Clinical Trials/TCTR20230314002
TCTR20230314002
Recruiting
Phase 1

Effect of intra-operative repeat knee flexion after capsule closed in one-stage bilateral Total knee arthroplasty: a randomized controlled trial

/A0 sites50 target enrollmentMarch 14, 2023
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ConditionsOsteoarthritis both kneesOA kneebilateral total knee arthroplastyknee flexion

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Osteoarthritis both knees
Sponsor
/A
Enrollment
50
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 14, 2023
End Date
September 30, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
/A

Eligibility Criteria

Inclusion Criteria

  • •Age 50\-85 years.
  • •American Society of Anesthesiologists (ASA) Classification 1, 2 or 3\.
  • •Diagnosed bilateral OA knees (Kellgren \& Lawrence classification Grade IV) by orthopaedist.
  • •All participants understand and inform consent.

Exclusion Criteria

  • •Patients have any infection.
  • •Body mass index \> 40 kg/m2
  • •Uncontrolled HT ( Systolic BP \> 180 mmHg or Diastolic BP \> 100 mmHg )
  • •Uncontrolled diabetic mellitus (HbA1C \> 8\.0 %)
  • •Patients with renal insufficiency (creatinine clearance \< 30 mL/min) and/or active
  • •hepatic disease who could not receive the general perioperative and post\-operative pain medicine protocol.
  • •Patients unable to undergo a spinal block.
  • •Patients with significantly pre\-operative stiff knees( flexion \< 90 degrees)

Outcomes

Primary Outcomes

Not specified

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