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Trial registered on ANZCTR


Registration number
ACTRN12609000390280
Ethics application status
Approved
Date submitted
8/05/2009
Date registered
1/06/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of continuous passive motion on range of movement, pain and function for patients who are slow to regain knee flexion range in the acute phase following total knee arthroplasty.
Scientific title
The effect of continuous passive motion on range of movement (ROM), pain and function for patients who are slow to regain knee flexion ROM in the acute phase following total knee arthroplasty.
Secondary ID [1] 262702 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total knee arthroplasty 4737 0
Condition category
Condition code
Musculoskeletal 237066 237066 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Group patients will be treated as for the Control Group, but, from day 3 onwards postoperatively,will in addition, receive continuous passive motion (CPM) for two hours twice a day. The CPM will be set up by a physiotherapist as follows. With the patient in supine, the hip and knee axes of the CPM unit will be aligned with the greater trochanter of the hip and the patient’s knee joint respectively and the length of the lower leg section of the CPM adjusted to fit the patient. Mid-thigh and mid-calf straps will then be secured. The range of movement of the CPM will be increased until it reaches the patient’s maximal tolerated range. The speed of the CPM will be adjusted up to the fastest tolerated speed. The CPM will be continued until such time as the patient can achieve 90 degrees of active knee flexion range of movement or is discharged from hospital.
Intervention code [1] 4511 0
Treatment: Devices
Comparator / control treatment
Control Group patients will be treated according to the standard Royal Adelaide Hospital postoperative physiotherapy protocol following total knee arthroplasty. This involves active knee range of movement exercises, quadriceps strengthening (static and inner range strengthening, and straight leg raise) and ambulation (using appropriate mobility aids), twice per day from days 1 to 4 postoperatively with the treating physiotherapist. Patients will be assisted in ambulation by one or two physiotherapists as required, or by nursing staff as mobility improves. Mobility will be progressed (in terms of the distance walked, speed of walking, degree of assistance required and mobility aids) as deemed clinically appropriate for each patient. Functional training over a single step will be commenced twice daily from day 3/4. From day 5 onwards, patients will be reviewed daily by the treating physiotherapist until their mobility is such that the patient is safe for discharge from hospital. Each rehabilitation session will last approximately 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 5907 0
Goniometric range of movement of the knee
Timepoint [1] 5907 0
Measured at days 3 and 5, and 6 weeks postoperatively
Secondary outcome [1] 241957 0
Severity of pain using a visual analogue scale (rated by the patient as the worst pain and best pain scores for the previous 24 hours)
Timepoint [1] 241957 0
Measured at days 3 and 5, and 6 weeks postoperatively
Secondary outcome [2] 241958 0
Functional assessment using the Iowa Level of Assistance Scale
Timepoint [2] 241958 0
Measured at days 3 and 5, and 6 weeks postoperatively
Secondary outcome [3] 241959 0
Patient-reported function using the Lower Extremity Functional Scale (LEFS) questionnaire
Timepoint [3] 241959 0
Measured at day 3 and 6 weeks postoperatively
Secondary outcome [4] 241960 0
Length of hospital stay
Timepoint [4] 241960 0
After discharge from hospital

Eligibility
Key inclusion criteria
All patients following elective total knee arthroplasty with less than 60 degrees active knee flexion range of movement on day 3 postoperatively.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unwilling to participate in the study. Patients who are unable to understand written or spoken English or co-operate with the assessment and treatment procedures. Patients who are unable to walk prior to admission. Patients who are partial weight bearing post-operatively or have limitations on permitted range of movement as directed by their orthopaedic surgeon.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After satisfying the selection criteria, potential participants will be approached by one of the investigators regarding participation. The investigator will explain the project aims and format to them, provide them with the written information sheet and, after allowing them time to consider whether or not they wish to participate, obtain informed written consent from those patients willing to participate. Once consent has been obtained, patients will be assigned to the treatment or control group by referring to sequential sealed opaque envelopes kept in the Physiotherapy Department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random numbers table will be used to generate these group allocations.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4915 0
Self funded/Unfunded
Name [1] 4915 0
Country [1] 4915 0
Primary sponsor type
Individual
Name
Tony McDonald
Address
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 4444 0
Individual
Name [1] 4444 0
Cameron Cramey
Address [1] 4444 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, 5000
Country [1] 4444 0
Australia
Secondary sponsor category [2] 4445 0
Individual
Name [2] 4445 0
Kathy Stiller
Address [2] 4445 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, 5000
Country [2] 4445 0
Australia
Secondary sponsor category [3] 4446 0
Individual
Name [3] 4446 0
Thomas Sullivan
Address [3] 4446 0
Data Management and Analysis Centre Discipline of Public Health, University of Adelaide, North Terrace, Adelaide, South Australia, 5000
Country [3] 4446 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6980 0
Research Ethics Committee, Royal Adelaide Hospital
Ethics committee address [1] 6980 0
Ethics committee country [1] 6980 0
Australia
Date submitted for ethics approval [1] 6980 0
06/05/2009
Approval date [1] 6980 0
27/05/2009
Ethics approval number [1] 6980 0
090515

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29584 0
Address 29584 0
Country 29584 0
Phone 29584 0
Fax 29584 0
Email 29584 0
Contact person for public queries
Name 12831 0
Tony McDonald
Address 12831 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, 5000
Country 12831 0
Australia
Phone 12831 0
61 8 82225334
Fax 12831 0
Email 12831 0
tony.mcdonald@health.sa.gov.au
Contact person for scientific queries
Name 3759 0
Kathy Stiller
Address 3759 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, 5000
Country 3759 0
Australia
Phone 3759 0
61 8 82225334
Fax 3759 0
Email 3759 0
kathy.stiller@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.