Effectiveness of Passive and Active ROM Exercises Following TKA

Osteoarthritis Clinical Trial

Official title:

Effectiveness of New Interventional Approaches to Improve Physical Function Following Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062138
• Other study ID #: EPAB
• Status: Completed
• Phase: N/A
• First received: February 6, 2014
• Last updated: May 19, 2017
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2017
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the effectiveness of new interventional approaches in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that active training programs are more effective in improving physical function than the passive standard-of-care therapy.

Description:

The major objectives of rehabilitation after TKA are the early regain of range of motion (ROM) and mobilization of the patient. Continuous passive motion (CPM) is frequently used as part of the postoperative care regime following TKA with the aim to increase knee joint mobility and improve postoperative recovery despite little conclusive scientific evidence. Conflicting research findings have generated an ongoing debate on its usage. As the greatest loss of function occurs in the first month following TKA, it is surprising that the ROM therapy during hospital stay is still carried out passively. A passive mobilization of the knee joint with CPM does not encourage the patients to actively participate in their rehabilitation. Research on the effectiveness of active ROM exercises added to standard physiotherapy during the short in-hospital period is lacking so far.The objective of this study is to compare the passive clinical standard therapy (CPM) with different active training programs (controlled active motion, CAM). It was hypothesised that the CAM therapies are more effective in improving physical function than the CPM therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with knee osteoarthritis and scheduled for primary TKA

• age: 50-80

Exclusion Criteria:

• BMI > 40

• musculoskeletal and neurological disorders that limit physical function

• any planned further joint surgery within 6 months

• substantial pain or functional limitation which make the patients unable to perform study procedures

Related Conditions & MeSH terms

• Osteoarthritis
• Total Knee Arthroplasty

Intervention

Other:
• continuous passive motion (CPM)
standard-of-care therapy (control intervention); Patients receive three 30 minutes CPM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.
• controlled active motion (CAM I)
Patients receive three 30 minutes CAM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.
• controlled active motion (CAM II)
Patients receive three 30 minutes CAM applications (bilateral alternating) each day from the second postoperative day until 1 day prior to discharge.

Locations

Country	Name	City	State
Germany	Department of Orthopedics, University Medicine Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	range of motion		change from baseline (before surgery) to discharge (9 days post surgery)
Secondary	neuromuscular function		change from baseline (before surgery) to discharge (9 days after surgery)
Secondary	joint position sense		change from baseline (before surgery) to discharge (9 days after surgery)
Secondary	motor function	stair climbing test, timed up and go test	change from baseline (before surgery) to discharge (9 days after surgery)
Secondary	cognitive functioning		change from baseline (before surgery) to discharge (9 days after surgery)
Secondary	physical activity	over a period of 7 days using the activPAL activity recording system.	change from baseline (before surgery) to discharge (9 days after surgery)
Secondary	pain	visual analogue scale (VAS)	change from baseline (before surgery) to discharge (9 days after surgery)
Secondary	swelling		change from baseline (before surgery) to discharge (9 days after surgery)
Secondary	length of hospital stay		change from baseline (before surgery) to discharge (9 days after surgery)
Secondary	quality of life	36-item Short Form Health Survey (SF-36)	change from baseline (before surgery) to discharge (9 days after surgery)

External Links

•   Biomechanics and Implant Technology Research Laboratory (ForBioMit), Department of Orthopedics, University Medicine Rostock
•   Exercise Science Research Laboratory, University of Rostock