Proprioception of the Knee Post MIS TKA and MIS-QS TKA

July 11, 2014 updated by: Jia-kuo yu

Prospective Randomized Comparative Study on the Proprioception of the Knee Post MIS TKA (Minimally Invasive Surgery Total Knee Arthroplasty) and MIS-QS(Quadriceps Sparing ) TKA

If the proprioception of the affected knee post total knee arthroplasty (TKA) can recover earlier, it will accelerate the regaining of motion control ability and motion control accuracy of the TKA patients. This study compared the proprioception difference of the post operation knees between the MIS-QS TKA group and the MIS TKA group.The differences of proprioception recovery were analyzed following the two different TKA procedures and the advantages of MIS-QS TKA in the recovery of knee. proprioception were discussed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were scheduled prospectively to undergo total knee arthroplasties were randomly assigned to receive either a MIS-QS TKA or a MIS TKA. Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation. Paired two-tailed t tests with a level of significance of p < 0.05 were used to assess the effect of the different arthroplasty procedure on the postoperative knee joint proprioception for all subjects.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing City, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of osteoarthritis
  • Indication of TKA

Exclusion Criteria:

  • Bilateral total knee replacements
  • Rheumatoid arthritis
  • Genu valgus over than 10 degrees and genu varum over 15 degrees
  • ROM (Range of motion) of preoperative knee joint less than 100 degree.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: QS-TKA
patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)
Procedure: total knee arthroplasty
Other Names:
  • total knee replacement
ACTIVE_COMPARATOR: MIS-TKA
patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)
Procedure: total knee arthroplasty
Other Names:
  • total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proprioception of the Knee Post Operation
Time Frame: six months

Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation.

Scale Name:degree scale range:0~180 degree,and a higher values represent a worse outcome
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HSS(Hospital for Special Surgery) Score of the Knee Joint
Time Frame: 6 months
Scale Name:score scale range:0~100,and a higher values represent a better outcome
6 months
VAS(Visual Analogue Scale/Score) of the Knee Joint
Time Frame: 6 months
Scale Name:score scale range:0~100,and a higher values represent a worse outcome
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jia-kuo yu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (ESTIMATE)

June 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QS-YU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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