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Clinical Trials/NCT02062138
NCT02062138
Completed
Not Applicable

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

University of Rostock1 site in 1 country60 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University of Rostock
Enrollment
60
Locations
1
Primary Endpoint
range of motion
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
April 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Rostock
Responsible Party
Principal Investigator
Principal Investigator

Anett Mau-Moeller

M.A.

University of Rostock

Eligibility Criteria

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

Outcomes

Primary Outcomes

range of motion

Time Frame: change from baseline (before surgery) to discharge (9 days post surgery)

Secondary Outcomes

  • neuromuscular function(change from baseline (before surgery) to discharge (9 days after surgery))
  • joint position sense(change from baseline (before surgery) to discharge (9 days after surgery))
  • motor function(change from baseline (before surgery) to discharge (9 days after surgery))
  • cognitive functioning(change from baseline (before surgery) to discharge (9 days after surgery))
  • physical activity(change from baseline (before surgery) to discharge (9 days after surgery))
  • pain(change from baseline (before surgery) to discharge (9 days after surgery))
  • swelling(change from baseline (before surgery) to discharge (9 days after surgery))
  • length of hospital stay(change from baseline (before surgery) to discharge (9 days after surgery))
  • quality of life(change from baseline (before surgery) to discharge (9 days after surgery))

Study Sites (1)

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