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The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01450904
First received: October 6, 2011
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis of Knee
 Procedure: Quadriceps incision < 2 cm
Procedure: Quadriceps incision 2-4 cm
Procedure: Quadriceps incision > 4 cm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty: The Effect of Quadriceps Incision Length

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • The recovery time of Quadriceps strength [ Time Frame: Upto 6 months ] [ Designated as safety issue: No ]
    Quadriceps strength was tested every month postoperatively, Recovery time was the amount of months which the Quadriceps strength returned to preoperative level.


Enrollment: 60
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
The length of Quadriceps incision was less than 2 cm.
 Procedure: Quadriceps incision < 2 cm
MIS-TKA was performed with less than 2 cm Quadriceps incision length
Experimental: Group B
The length of Quadriceps incision was 2 to 4 cm.
 Procedure: Quadriceps incision 2-4 cm
MIS-TKA was performed with 2 to 4 cm Quadriceps incision length
Experimental: Group C
The length of Quadriceps incision was more than 4 cm.
 Procedure: Quadriceps incision > 4 cm
MIS-TKA was performed with more than 4 cm Quadriceps incision length

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450904

Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Keerati Charoencholvanich, MD Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01450904     History of Changes
Other Study ID Numbers: Si051/2554(EC2)
Study First Received: October 6, 2011
Last Updated: October 10, 2011
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013