Contact information
Type
Scientific
Primary contact
Mr Ton Lenssen
ORCID ID
Contact details
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
Does the intensity of PT treatment (once versus twice daily) in patients following TKA have an influence on short-term recovery, measured in range of motion and function?
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 in OA patients
Intervention
Intensive PT versus regular PT
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Primary outcome measures in this study were mobility and function
Secondary outcome measures
Secondary outcome measures were length of stay (LOS) following surgery, pain over the last 24 hours, satisfaction with treatment, satisfaction with the intermediate treatment results, number of PT sessions and Global perceived effect.
Overall trial start date
15/01/2004
Overall trial end date
01/08/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients who received a primary TKA at the University Hospital Maastricht between January 15 and June 1st, 2004. Subjects were considered eligible for the study if they were scheduled in the Joint Care program and signed an informed consent form.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
43
Participant exclusion criteria
Patients undergoing knee revision surgery were excluded. Also patients over 85 years of age, patients with co-morbidity influencing gait and patient who did not understand or speak Dutch were excluded.
Recruitment start date
15/01/2004
Recruitment end date
01/08/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.Debijelaan 25
Maastricht
6229 HX
Netherlands
Sponsor information
Organisation
University Hospital Maastricht (The Netherlands)
Sponsor details
P.debijelaan 25
Maastricht
6229HX
Netherlands
+31 (0)43 3876543
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
2006 results in ://www.ncbi.nlm.nih.gov/pubmed/16942627
Publication citations
-
Lenssen AF, Crijns YH, Waltjé EM, van Steyn MJ, Geesink RJ, van den Brandt PA, de Bie RA, Efficiency of immediate postoperative inpatient physical therapy following total knee arthroplasty: an RCT., BMC Musculoskelet Disord, 2006, 7, 71, doi: 10.1186/1471-2474-7-71.