Contact information
Type
Scientific
Primary contact
Mr Ton Lenssen
ORCID ID
Contact details
University Hospital Maastricht
P Debijelaan 25
Maastricht
6229 HX
Netherlands
+31 (0)433875145
alen@pmzl.azm.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
What is the effect on range of motion and functional status of prolonged use of a continuous passive motion device at home in addition to physical therapy, compared to physical therapy alone, in patients with limited flexion range of motion (less than 80°) of the knee at discharge from the hospital following total knee arthroplasty?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Total knee arthroplasty
Intervention
Physical therapy versus physical therapy + continuous passive motion
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Functional status and range of motion
Secondary outcome measures
Perceived effect, postoperative medication use, satisfaction with treatment, satisfaction with treatment result, adherence to treatment protocols and use of CPM (in hours)
Overall trial start date
01/04/2005
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with knee osteoarthritis (OA) undergoing TKA and experiencing early postoperative flexion impairment (less than 80° of knee flexion at the time of discharge).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant exclusion criteria
Patients will be excluded if they need to stay in hospital for more than 5 days after surgery or show relevant co-morbidity influencing mobility (e.g. claudication, other prosthesis) or are operated upon using minimally invasive surgery.
Recruitment start date
01/04/2005
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Hospital Maastricht
Maastricht
6229 HX
Netherlands
Sponsor information
Organisation
University Hospital Maastricht (The Netherlands)
Sponsor details
P Debijelaan 25
Maastricht
6229 HX
Netherlands
+31 (0)433876543
groo@pmzl.azm.nl
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University Hospital Maastricht (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Effectiviteit van CPM in de klinische nabehandeling van totale knie protheses:
Een systematische review. Nederlands tijdschrift voor fysiotherapie December 2001: 111: 152-159. A.F.Lenssen, A.J.A. Köke, R.A.de Bie
Continuous passive motion following primary total knee arthroplasty: short and long term effects on range of motion. Physical therapy reviews 2003;8;113-121. A.F. Lenssen, A.J.A. Koke, R.A. De Bie, R.G.T. Geesink
Continuous passive motion following primary total knee arthroplasty: a randomized controlled trial. Physical therapy reviews 2003;8;123-129. A.F. Lenssen, R.A. De Bie, S.K.Bulstra, M.J.A. Van Steyn
Design in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16504087
Publication citations
-
Design
Lenssen AF, Crijns YH, Waltjé EM, Roox GM, van Steyn MJ, Geesink RJ, van den Brandt PA, de Bie RA, Effectiveness of prolonged use of continuous passive motion (CPM) as an adjunct to physiotherapy following total knee arthroplasty: design of a randomised controlled trial [ISRCTN85759656]., BMC Musculoskelet Disord, 2006, 7, 15, doi: 10.1186/1471-2474-7-15.