Efficiency of immediate postoperative inpatient physical therapy (PT) following total knee arthroplasty: a randomised controlled trial (RCT)

ISRCTN	ISRCTN49658674
DOI	https://doi.org/10.1186/ISRCTN49658674
Protocol serial number	N/A
Sponsor	University Hospital Maastricht (The Netherlands)
Funder	University Hospital Maastricht (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Ton Lenssen
Scientific

P.Debijelaan 25
Maastricht
6229 HX
Netherlands

Phone	+31 (0)433875145
Email	alen@pmzl.azm.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Efficiency of immediate postoperative inpatient physical therapy (PT) following total knee arthroplasty: a randomised controlled trial (RCT)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Total knee arthroplasty in OA patients
Intervention	Intensive PT versus regular PT
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Primary outcome measures in this study were mobility and function
Key secondary outcome measure(s)	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.
Completion date	01/08/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	43
Total final enrolment	43
Key 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.
Key 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.
Date of first enrolment	15/01/2004
Date of final enrolment	01/08/2004

P.Debijelaan 25

Maastricht
6229 HX
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		31/08/2006		Yes	No

08/11/2022: The final enrolment number has been added.