NCT03218267

Brief Summary

Total hip replacement (THR) is the procedure which can improve the quality of life in patients with osteoarthritis. However, deficits in static stability and impairment of the lower limb efficiency can be observed even several months after procedure. The aim of this study was to investigate the static balance of the standing position in patients treated by THR.

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 Sep 2014

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 10, 2017

Last Update Submit

July 12, 2017

Conditions

Keywords

total hip replacementstatic disbalance

Outcome Measures

Primary Outcomes (1)

  • Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects.

    Mean COP velocity \[mm/s\] and the value of the middle of spectrum \[Hz; mm\] is recorded in anteroposterior (AP) and mediolateral (ML) directions within posturographic evaluation in examination of every participant Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects. Mean COP velocity \[mm/s\] and the value of the middle of spectrum \[Hz; mm\] is recorded in anteroposterior (AP) and mediolateral (ML) directions within posturographic evaluation in examination of every participant

    6 months

Secondary Outcomes (1)

  • Evaluation of the time of maintain one-leg standing position by the patients.

    6 months

Study Arms (2)

Individuals after total hip replacement

EXPERIMENTAL

Individuals after total hip replacement. Patients treated at the Out-Patient Ward of W. Dega Orthopaedic-Rehabilitation Clinical Hospital of Karol Marcinkowski University of Medical Sciences in Poznań. The examination of participants included the static posturography and one-leg standing test.

Other: Static PosturographyOther: One-leg standing test (OLS)

control group

ACTIVE COMPARATOR

The group with healthy individuals; without total hip replacement. The examination of participants included the static posturography and one-leg standing test.

Other: Static PosturographyOther: One-leg standing test (OLS)

Interventions

The balance platform (Good Balance by Metitur) and one leg standing test (OLS) were used to assess the static balance. OLS test was performed on left and right foot separately. The static posturography was performed with several various positions of feet. Position : normal standing with eyes open and eyes closed - an upright standing with feet placed parallel 20 cm apart for 30 s. Position: tandem - a stance with one foot placed ahead of the other for 10 s. Position: second form of tandem - a stance with one foot placed ahead of the other with feet placed on both sides of the line dividing platform to two parts for 20s. Position: one leg standing: stance on the one leg for 5 s.

Individuals after total hip replacementcontrol group

During the one-leg standing test (OLS) the time of maintain this position by the patients was measured. The placement of the limbs was the same as in the case of the balance platform test. Subjects performed 3 trials on each lower limb. Time ended when subject either: loosed balance and touched raised foot the floor, moved supporting leg on the ground, a significant loss of balance or a maximum of 60 s had elapsed. Results achieved by the subjects after THR on both operated (OLS-O) and non operated limbs (OLS-N) were compared with the index of the control group (OLS-C: mean result of the tests performed on the left and right legs).

Individuals after total hip replacementcontrol group

Eligibility Criteria

Age59 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • for patients: total hip replacement the minimum of 6 months period since the procedure, age above 55 years, unassisted gait, and the minimum of 9 points on the AMTS scale
  • for healthy volunteers: without total hip replacement age above 55 years, unassisted gait, and the minimum of 9 points on the AMTS scale

You may not qualify if:

  • for patients: neurological diseases, muscles diseases, rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) and sciatica. Additionally we excluded patients who had operations in the area of the spine and lower limbs (knee arthroscopy with ACL reconstruction or meniscectomy, total knee replacement, total hip replacement in both extremities, osteotomy or arthrodesis).
  • for healthy volunteers: neurological diseases, muscles diseases, rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) and sciatica. Additionally we excluded patients who had operations in the area of the spine and lower limbs (knee arthroscopy with ACL reconstruction or meniscectomy, total knee replacement, total hip replacement in both extremities, osteotomy or arthrodesis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Wykman A, Goldie I. Postural stability after total hip replacement. Int Orthop. 1989;13(4):235-8. doi: 10.1007/BF00268504.

    PMID: 2599698BACKGROUND
  • Nantel J, Termoz N, Ganapathi M, Vendittoli PA, Lavigne M, Prince F. Postural balance during quiet standing in patients with total hip arthroplasty with large diameter femoral head and surface replacement arthroplasty. Arch Phys Med Rehabil. 2009 Sep;90(9):1607-12. doi: 10.1016/j.apmr.2009.01.033.

    PMID: 19735790BACKGROUND
  • Calo L, Rabini A, Picciotti PM, Laurino S, Passali GC, Ferrara PE, Maggi L, Piazzini DB, Specchia A, Frasca G, Ronconi G, Bertolini C, Scarano E. Postural control in patients with total hip replacement. Eur J Phys Rehabil Med. 2009 Sep;45(3):327-34. Epub 2009 Feb 11.

    PMID: 19209135BACKGROUND
  • Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.

    PMID: 19839175BACKGROUND
  • Lui RC, Johnson FE, Horovitz JH, Cunningham JN Jr. Aortoesophageal fistula: case report and literature review. J Vasc Surg. 1987 Oct;6(4):379-82. doi: 10.1067/mva.1987.avs0060379.

    PMID: 3309380BACKGROUND
  • Balogun JA, Ajayi LO, Alawale F. Determinants of single limb stance balance performance. Afr J Med Med Sci. 1997 Sep-Dec;26(3-4):153-7.

    PMID: 10456159BACKGROUND
  • Truszczynska A, Drzal-Grabiec J, Rapala K, Gmitrzykowska E. Postural stability in patients with osteoarthritis of the hip. Pilot study. Ortop Traumatol Rehabil. 2013 Nov-Dec;15(6):567-73. doi: 10.5604/15093492.1091512.

    PMID: 24662903BACKGROUND
  • Rougier P, Belaid D, Cantalloube S, Lamotte D, Deschamps J. Quiet postural control of patients with total hip arthroplasty following joint arthritis. Motor Control. 2008 Apr;12(2):136-50. doi: 10.1123/mcj.12.2.136.

    PMID: 18483448BACKGROUND
  • Warenczak A, Lisinski P. Does total hip replacement impact on postural stability? BMC Musculoskelet Disord. 2019 May 17;20(1):229. doi: 10.1186/s12891-019-2598-9.

Study Officials

  • Przemysław Lisiński, PhD, Prof.

    Poznan University of Medical Sciences

    STUDY DIRECTOR
  • Agnieszka Wareńćzak, PhD

    Poznan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant, MSc

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 14, 2017

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

May 1, 2016

Last Updated

July 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share