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Changes of the Single Limb Standing Balance After Total Knee Arthroplasty in Degenerative Osteoarthritis

This study is currently recruiting participants.
Verified December 2011 by Ulsan University Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Ho Hwang, Ulsan University Hospital
ClinicalTrials.gov Identifier:
NCT01192334
First received: August 30, 2010
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  Purpose

It was well known that total knee arthroplasty could improve the previously impaired proprioception in degenerative osteoarthritis. Most current researches have been focused on the change of the proprioception. However, the evaluation of the proprioception is based on the surrogated end.

Double or single limb standing balance is considered functional scale. It is very important view for the prevention of slipping down injury in evidence-based approaches for knee osteoarthritis.

Unfortunately, few study have been performed for figuring proprioceptive change after surgery out.

Considering the similarity between the proprioception and the standing balance and reported positive result in proprioception after total knee arthroplasty, the investigators supposed that total knee arthroplasty might give an influence on the recovery of single limb standing balance.


Condition
Knee Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study for Changes of the Single Limb Standing Balance After Total Knee Arthroplasty in Degenerative Osteoarthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ulsan University Hospital:

Primary Outcome Measures:
  • single limb standing balance [ Time Frame: from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks ] [ Designated as safety issue: No ]
    migration distance of center of pressure while single limb standing was recorded through balance performance monitoring

  • single limb standing balance [ Time Frame: from the surgery until the time in which patient shows the same pain score as the pre-operation pain score up to the post-operative 4 weeks, average time of this measurement is post-operative 2 weeks ] [ Designated as safety issue: No ]
    migration distance of center of pressure while single limb standing was recorded through balance performance monitoring

  • single limb standing balance [ Time Frame: post-operative 6 months ] [ Designated as safety issue: No ]
    migration distance of center of pressure while single limb standing was recorded through balance performance monitoring

  • single limb standing balance [ Time Frame: post-operative 12 months ] [ Designated as safety issue: No ]
    migration distance of center of pressure while single limb standing was recorded through balance performance monitoring


Secondary Outcome Measures:
  • balance index [ Time Frame: from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks ] [ Designated as safety issue: No ]
    balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine

  • balance index [ Time Frame: post-operative 6 months ] [ Designated as safety issue: No ]
    balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine

  • balance index [ Time Frame: post-operative 12 months ] [ Designated as safety issue: No ]
    balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine


Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients to be scheduled to take a elective unilateral total knee arthroplasty

Criteria

Inclusion Criteria:

  • Medial compartment degenerative knee osteoarthritis showing the varus deformity

Exclusion Criteria:

  • History of surgery on the lower extremity except for arthroscopy or menisectomy
  • Hip arthritis or, hip or back pain disturbing the standing
  • History of participation in sport rehabilitation program within less than 6 months
  • Presence of neurological or musculoskeletal disease disturbing the standing
  • Patient to reject the participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192334

Contacts
Contact: Chang Ho Hwang, M.D. +82-052-250-8898 chhwang1220ciba@yahoo.co.kr

Locations
Korea, Republic of
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 682-714
Contact: Chang Ho Hwang, M.D.     +82-052-250-8898     chhwang1220ciba@yahoo.co.kr    
Principal Investigator: Chang Ho Hwang, M.D,M.M.Sc            
Sub-Investigator: Sung Do Cho, M.D, PhD            
Sub-Investigator: Dae-Sik Son, M.D.            
Sponsors and Collaborators
Ulsan University Hospital
Investigators
Study Director: Chang Ho Hwang, M.D. Ulsan University Hospital
  More Information

No publications provided

Responsible Party: Chang Ho Hwang, Clinical Associate Professor, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT01192334     History of Changes
Other Study ID Numbers: chhwang1
Study First Received: August 30, 2010
Last Updated: December 9, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Ulsan University Hospital:
knee osteoarthritis arthroplasty postural balance

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

ClinicalTrials.gov processed this record on May 16, 2013