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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192334
• Other study ID #: chhwang1
• Status: Completed
• Phase: N/A
• First received: August 30, 2010
• Last updated: December 22, 2013
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	single limb standing balance	migration distance of center of pressure while single limb standing was recorded through balance performance monitoring	from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks	No
Primary	single limb standing balance	migration distance of center of pressure while single limb standing was recorded through balance performance monitoring	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	No
Primary	single limb standing balance	migration distance of center of pressure while single limb standing was recorded through balance performance monitoring	post-operative 6 months	No
Primary	single limb standing balance	migration distance of center of pressure while single limb standing was recorded through balance performance monitoring	post-operative 12 months	No
Secondary	balance index	balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine	from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks	No
Secondary	balance index	balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine	post-operative 6 months	No
Secondary	balance index	balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine	post-operative 12 months	No