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Completed

NCT Number: NCT02062138

Effectiveness of Passive and Active ROM Exercises Following TKA

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Total Knee Arthroplasty

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedics, University Medicine Rostock

Rostock, 18057, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

continuous passive motion (CPM)

Other

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)

Other

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)

Other

Patients receive three 30 minutes CAM applications (bilateral alternating) each day from the second postoperative day until 1 day prior to discharge.

Primary outcomes

  1. range of motion

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

Secondary outcomes

  1. neuromuscular function

    Time frame: change from baseline (before surgery) to discharge (9 days after surgery)

  2. joint position sense

    Time frame: change from baseline (before surgery) to discharge (9 days after surgery)

  3. motor function

    Time frame: change from baseline (before surgery) to discharge (9 days after surgery)

    stair climbing test, timed up and go test

  4. cognitive functioning

    Time frame: change from baseline (before surgery) to discharge (9 days after surgery)

  5. physical activity

    Time frame: change from baseline (before surgery) to discharge (9 days after surgery)

    over a period of 7 days using the activPAL activity recording system.

  6. pain

    Time frame: change from baseline (before surgery) to discharge (9 days after surgery)

    visual analogue scale (VAS)

  7. swelling

    Time frame: change from baseline (before surgery) to discharge (9 days after surgery)

  8. length of hospital stay

    Time frame: change from baseline (before surgery) to discharge (9 days after surgery)

  9. quality of life

    Time frame: change from baseline (before surgery) to discharge (9 days after surgery)

    36-item Short Form Health Survey (SF-36)

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 13, 2014
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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