Partial Synovectomy in Articular Side of Quadriceps Tendon Verified to Reduce Crepitus in Retrospective Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorGangnam Severance Hospital
About this trial
Crepitus causing unsatisfied result to patients after posterior stabilized total knee arthroplasty. Recent retrospective study demonstrated removal of hyperplastic synovium in distal quadriceps caused reduce of crepitus. However, this study has limitation of time gap exist between arms, different in observation time and bias caused by retrospective review. Thus aim of this study is that by randomized trial, verified hyperplastic synovium in distal quadriceps causing crepitus.
Target enrolled patients in this study are scheduled to perform both total knee arthroplasty. Experimental group is randomized side (right or left) of knee, and control group is other side of knee. Both arms decided by randomized number table. Crepitus measured after 3mo, 6mo, 1year after surgical treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Lost follow up (Including death of patient)
Unexpected complication (e.g) Infection, periprosthetic fracture)
Patella resurfacing
Canceled surgical treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Prepectoral
Procedure/SurgeryRemove all visible synovium in suprapatellar area under distal quadriceps tendon. All other procedures (Total Knee arthroplasty) are same with no intervention arm.
Subpectoral
Procedure/SurgeryNo remove any synovium in suparapatellar area under distal quadriceps tendon. All other preocedures are same with experimental arm.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Synovium removal groupExperimental treatment 2 interventions
Group B: Synovium sustain groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Crepitus grade
Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus
Time frame
3month, 6month, 1year after surgical treatmentSecondary outcomes
1
Hip knee ankle angle
Identify postop alignment of lower extrimities, which is mechanical axis between femur and tibia in scanogram of low extremity.
Time frame
3month, 6month, 1year after surgical treatment2
Insall-Salvati ratio
Measured in true lateral position in 30' knee flextion, measureing patellar position in lateral plain radiograph of knee.
Time frame
3month, 6month, 1year after surgical treatment3
Patellar displacement
Measuring patellar position in merchant view of plain radiograph.
Time frame
3month, 6month, 1year after surgical treatment4
Patellar tilt angle
Measuring patellar position in merchant view of plain radiograph.
Time frame
3month, 6month, 1year after surgical treatmentSponsors and contacts
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Source ClinicalTrials.gov