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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01450904
Other study ID # Si051/2554(EC2)
Secondary ID
Status Completed
Phase N/A
First received October 6, 2011
Last updated October 10, 2011
Start date April 2011
Est. completion date October 2011

Study information

Verified date October 2011
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had the less postoperative pain and shorter recovery time compared to the conventional technique. With using MIS technique, less cut of quadriceps tendon was the key. It related to keep more quadriceps strength and improve functional performance after TKA. However, there was no previous studies about the effect of quadriceps incision length in the recovery time of the quadriceps strength. The investigators hypothesized that longer quadriceps incision affected the longer recovery time of quadriceps strength in MIS-TKA.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

- The patients who diagnosed primary osteoarthritis of knee with

1. varus or valgus deformity < 20 degrees

2. preoperative range of motion > 90 degrees

3. extension lag < 10 degrees

4. Flexion contracture < 30 degrees

Exclusion Criteria:

- Bilateral simultaneous total knee arthroplasty

- Previous knee surgery

- Inadequate exposure during the surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Quadriceps incision < 2 cm
MIS-TKA was performed with less than 2 cm Quadriceps incision length
Quadriceps incision 2-4 cm
MIS-TKA was performed with 2 to 4 cm Quadriceps incision length
Quadriceps incision > 4 cm
MIS-TKA was performed with more than 4 cm Quadriceps incision length

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Outcome

Type Measure Description Time frame Safety issue
Primary The recovery time of Quadriceps strength Quadriceps strength was tested every month postoperatively, Recovery time was the amount of months which the Quadriceps strength returned to preoperative level. Upto 6 months No
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