Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Tricompartmental Gonarthrosis
• Interventions: Procedure: Mid - Vastus arthrotomy; Procedure: Sub-Vastus arthrotomy

• Registration Number: NCT00925626
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach".

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-05
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients diagnosed with osteoarthrosis of the knee
• patients must be in good general health condition

Exclusion Criteria

• patients with morbid obesity (BMI >45)
• patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mid-Vastus arthrotomy	Mid - Vastus arthrotomy	Mid-vastus arthrotomy
Sub - Vastus arthrotomy	Sub-Vastus arthrotomy	Sub-vastus arthrotomy

Primary Outcome Measures

Name	Time	Method
VAS, KOOS and HSS scales	at day 1, day 2, day 3, day 4 and day 5 post-operatively
Rehabilitation time; time needed for 90° flexion of the knee joint	post-operatively

Secondary Outcome Measures

Name	Time	Method
VAS, HSS, KOOS questionnaires	at 6 weeks, 3 months and 12 months after surgery.
Amount and type of analgesic drugs used.	pre-operatively and post-operatively

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium