NCT02062138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

February 6, 2014

Last Update Submit

May 19, 2017

Conditions

OsteoarthritisTotal Knee Arthroplasty

Keywords

rehabilitationtotal knee arthroplastyrange of motioncontinuous passive motioncontrolled active motionpostoperative physical therapy

Outcome Measures

Primary Outcomes (1)

  • range of motion

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

Secondary Outcomes (9)

  • 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)

  • +4 more secondary outcomes

Study Arms (3)

continuous passive motion (CPM)

ACTIVE COMPARATOR
Other: continuous passive motion (CPM)

controlled active motion (CAM I)

EXPERIMENTAL
Other: controlled active motion (CAM I)

controlled active motion (CAM II)

EXPERIMENTAL
Other: controlled active motion (CAM II)

Interventions

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.

continuous passive motion (CPM)
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 I)
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.

controlled active motion (CAM II)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with knee osteoarthritis and scheduled for primary TKA
  • age: 50-80

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedics, University Medicine Rostock

Rostock, 18057, Germany

Location

Related Publications (1)

  • Jacksteit R, Stockel T, Behrens M, Feldhege F, Bergschmidt P, Bader R, Mittelmeier W, Skripitz R, Mau-Moeller A. Low-Load Unilateral and Bilateral Resistance Training to Restore Lower Limb Function in the Early Rehabilitation After Total Knee Arthroplasty: A Randomized Active-Controlled Clinical Trial. Front Med (Lausanne). 2021 Jun 22;8:628021. doi: 10.3389/fmed.2021.628021. eCollection 2021.

    PMID: 34239883DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Motion Therapy, Continuous Passive

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesMusculoskeletal Manipulations

Study Officials

  • Rainer Bader, MD

    Department of Orthopedics, University Medicine Rostock

    STUDY CHAIR

  • Ralf Skripitz, MD

    Department of Orthopedics, University Medicine Rostock

    STUDY DIRECTOR

  • Anett Mau-Moeller, M.A.

    Department of Orthopedics, University Medicine Rostock

    PRINCIPAL INVESTIGATOR

  • Martin Behrens

    Department of Kinesiology, University of Rostock

    PRINCIPAL INVESTIGATOR

  • Tino Stöckel, PhD

    Department of Kinesiology, University of Rostock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.A.

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 13, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

May 22, 2017

Record last verified: 2017-05

Locations

DE(1)