NCT03215160

Brief Summary

There is no definite evidence about the most effective treatment approach in early-stage rehabilitation after total knee arthroplasty surgery. The purpose of this study is to investigate the effects of mobilization exercises applied with classical exercises on pain, joint range of motion, edema, function, quality of life and patient satisfaction in early stage rehabilitation after total knee arthroplasty surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 19, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

July 22, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

June 19, 2017

Last Update Submit

July 16, 2018

Conditions

Keywords

MobilizationManual TherapiesExercise

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Range of Motion Degree at 2 weeks

    Passive knee flexion range of motion

    Baseline, Post-op 2 weeks, and Post-op 2 months

Secondary Outcomes (2)

  • Change from Baseline Pain Degree at 2 weeks

    Baseline, Post-op 2 weeks, and Post-op 2 months

  • Function

    Baseline, Post-op 2 weeks, and Post-op 2 months

Other Outcomes (1)

  • Satisfaction levels of the patients

    At 2 months

Study Arms (2)

Mobilization Exercise Group

EXPERIMENTAL

Mobilization exercises in addition to classical exercises performed in the early post-op period

Behavioral: Exercises

Classical Exercise Group

ACTIVE COMPARATOR

only classical exercises performed in the early post-op period

Behavioral: Exercises

Interventions

ExercisesBEHAVIORAL

mobilization exercises (Patellofemoral joint, Tibiofemoral joint, Soft tissue) and classical exercises performed in the early post-op period

Classical Exercise GroupMobilization Exercise Group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with TKA surgery due to the diagnosis of knee OA
  • Between the ages of 50-75 years

You may not qualify if:

  • Revision TKA,
  • Previous unicompartmental arthroplasty or tibial osteotomy,
  • Hemophilia,
  • Rheumatic diseases,
  • Lower extremity fractures and tumors,
  • Neurological diseases leading to muscle weakness in the lower limbs,
  • Patients with emotional and cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, 34740, Turkey (Türkiye)

Location

Related Publications (9)

  • Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev. 2014 Feb 6;2014(2):CD004260. doi: 10.1002/14651858.CD004260.pub3.

    PMID: 24500904BACKGROUND
  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

    PMID: 24553908BACKGROUND
  • Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.

    PMID: 24387819BACKGROUND
  • Jacobs CA, Christensen CP. Factors influencing patient satisfaction two to five years after primary total knee arthroplasty. J Arthroplasty. 2014 Jun;29(6):1189-91. doi: 10.1016/j.arth.2014.01.008. Epub 2014 Jan 21.

    PMID: 24534535BACKGROUND
  • Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.

    PMID: 20710093BACKGROUND
  • Noble PC, Gordon MJ, Weiss JM, Reddix RN, Conditt MA, Mathis KB. Does total knee replacement restore normal knee function? Clin Orthop Relat Res. 2005 Feb;(431):157-65. doi: 10.1097/01.blo.0000150130.03519.fb.

    PMID: 15685070BACKGROUND
  • Ebert JR, Munsie C, Joss B. Guidelines for the early restoration of active knee flexion after total knee arthroplasty: implications for rehabilitation and early intervention. Arch Phys Med Rehabil. 2014 Jun;95(6):1135-40. doi: 10.1016/j.apmr.2014.02.015. Epub 2014 Mar 3.

    PMID: 24602550BACKGROUND
  • Bade MJ, Stevens-Lapsley JE. Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. J Orthop Sports Phys Ther. 2011 Dec;41(12):932-41. doi: 10.2519/jospt.2011.3734. Epub 2011 Sep 30.

    PMID: 21979411BACKGROUND
  • Karaborklu Argut S, Celik D, Kilicoglu OI. The Combination of Exercise and Manual Therapy Versus Exercise Alone in Total Knee Arthroplasty Rehabilitation: A Randomized Controlled Clinical Trial. PM R. 2021 Oct;13(10):1069-1078. doi: 10.1002/pmrj.12542. Epub 2021 Feb 3.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Research Assistant

Study Record Dates

First Submitted

June 19, 2017

First Posted

July 12, 2017

Study Start

July 22, 2017

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations