NCT01450904

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

October 6, 2011

Last Update Submit

October 10, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group A

EXPERIMENTAL

The length of Quadriceps incision was less than 2 cm.

Procedure: Quadriceps incision < 2 cm

Group B

EXPERIMENTAL

The length of Quadriceps incision was 2 to 4 cm.

Procedure: Quadriceps incision 2-4 cm

Group C

EXPERIMENTAL

The length of Quadriceps incision was more than 4 cm.

Procedure: Quadriceps incision > 4 cm

Interventions

MIS-TKA was performed with less than 2 cm Quadriceps incision length

Group A

MIS-TKA was performed with 2 to 4 cm Quadriceps incision length

Group B

MIS-TKA was performed with more than 4 cm Quadriceps incision length

Group C

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who diagnosed primary osteoarthritis of knee with
  • varus or valgus deformity \< 20 degrees
  • preoperative range of motion \> 90 degrees
  • extension lag \< 10 degrees
  • Flexion contracture \< 30 degrees

You may not qualify if:

  • Bilateral simultaneous total knee arthroplasty
  • Previous knee surgery
  • Inadequate exposure during the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Keerati Charoencholvanich, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 12, 2011

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 12, 2011

Record last verified: 2011-10