Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877733
• Other study ID #: 2012/1678
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: July 2015

Study information

• Verified date: April 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of maximal strength training (MST) compared to standard rehabilitation in patients operated with total knee arthroplasty. Previous studies report reduced physical function and muscle strength despite successful surgery inserting an artificial implant.

Furthermore, great loss of muscle strength has been found in these patients in the early postoperative phase.

The study is a randomized controlled trial. The investigators hypothesize that MST will increase muscle strength and physical function more than standard rehabilitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• unilateral osteoarthritis,

• < 75 years

Exclusion Criteria:

• disease(s) that compromise testing/training,

• unable to understand written and verbal instructions and information,

• osteoarthritis in the contralateral leg that needs treatment.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Maximal strength training

Locations

Country	Name	City	State
Norway	St. Olavs hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Central Norway Regional Health Authority, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Husby VS, Foss OA, Husby OS, Winther SB. Randomized controlled trial of maximal strength training vs. standard rehabilitation following total knee arthroplasty. Eur J Phys Rehabil Med. 2018 Jun;54(3):371-379. doi: 10.23736/S1973-9087.17.04712-8. Epub 2017 — View Citation

Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength in leg extension and leg press	Measured preoperatively implies measuring the outcome within the last month prior to surgery	Measured preoperatively, after 7 days, 10 wks and 1 year
Secondary	6 minute walk test	Measuring the outcome preoperatively implies testing within the last month prior to surgery	preopertively, 7 days postoperatively and after 1 year
Secondary	KOOS; Knee injury and osteosarthritis outcome score		Preoperatively (within 1 month prior to surgery), 7 days postoperatively and 10 wks and 1 year postoperatively
Secondary	EQ-5D (measure of health outcome)		Preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively
Secondary	VAS scale recording pain		preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively