Effectiveness of prolonged use of continuous passive motion (CPM) as an adjunct to physiotherapy following total knee arthroplasty (TKA)

ISRCTN	ISRCTN85759656
DOI	https://doi.org/10.1186/ISRCTN85759656
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

University Hospital Maastricht
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	Effectiveness of prolonged use of continuous passive motion (CPM) as an adjunct to physiotherapy following total knee arthroplasty (TKA)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Total knee arthroplasty
Intervention	Physical therapy versus physical therapy + continuous passive motion
Intervention type	Other
Primary outcome measure(s)	Functional status and range of motion
Key secondary outcome measure(s)	Perceived effect, postoperative medication use, satisfaction with treatment, satisfaction with treatment result, adherence to treatment protocols and use of CPM (in hours)
Completion date	01/10/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	70
Key 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).
Key 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.
Date of first enrolment	01/04/2005
Date of final enrolment	01/10/2006

University Hospital Maastricht

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article		01/06/2003	Yes	No
Results article	results	29/04/2008	Yes	No
Protocol article	protocol	23/02/2006	Yes	No

14/09/2017: Publication reference added.