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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03215160
Other study ID # 22595
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 22, 2017
Est. completion date December 15, 2017

Study information

Verified date July 2018
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. Patients with bicompartmental total knee arthroplasty operation due to knee osteoarthritis will randomly assign to 2 groups. Patients in group 1 will treat with mobilization exercises in addition to classical exercises performed in the early post-op period; patients in group 2 will treat only with classical exercises.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 15, 2017
Est. primary completion date December 15, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients with TKA surgery due to the diagnosis of knee OA

- Between the ages of 50-75 years

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Istanbul University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Satisfaction levels of the patients Satisfaction levels of the patients with Global Rating of Change Score At 2 months
Primary 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 Change from Baseline Pain Degree at 2 weeks Patient reported pain degree Baseline, Post-op 2 weeks, and Post-op 2 months
Secondary Function Functional Performance tests Baseline, Post-op 2 weeks, and Post-op 2 months
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