Condition category
Musculoskeletal Diseases
Date applied
26/08/2005
Date assigned
07/09/2005
Last edited
08/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.azm.nl

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

  1. 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.

Additional files

Editorial Notes