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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Ho Hwang, Ulsan University Hospital
ClinicalTrials.gov Identifier:
NCT01192334
First received: August 30, 2010
Last updated: December 22, 2013
Last verified: December 2013
  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:


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


Enrollment: 50
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192334

Locations
Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
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 22, 2013
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 October 20, 2014