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
Secondary identifying numbers N/A
Submission date
26/08/2005
Registration date
07/09/2005
Last edited
14/09/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Ton Lenssen
Scientific

University Hospital Maastricht
P Debijelaan 25
Maastricht
6229 HX
Netherlands

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typeTreatment
Scientific titleEffectiveness of prolonged use of continuous passive motion (CPM) as an adjunct to physiotherapy following total knee arthroplasty (TKA)
Study objectivesWhat 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) studiedTotal knee arthroplasty
InterventionPhysical therapy versus physical therapy + continuous passive motion
Intervention typeOther
Primary outcome measureFunctional status and range of motion
Secondary outcome measuresPerceived effect, postoperative medication use, satisfaction with treatment, satisfaction with treatment result, adherence to treatment protocols and use of CPM (in hours)
Overall study start date01/04/2005
Completion date01/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants70
Key inclusion criteriaPatients 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 criteriaPatients 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 enrolment01/04/2005
Date of final enrolment01/10/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Hospital Maastricht
Maastricht
6229 HX
Netherlands

Sponsor information

University Hospital Maastricht (The Netherlands)
University/education

P Debijelaan 25
Maastricht
6229 HX
Netherlands

Phone +31 (0)433876543
Email groo@pmzl.azm.nl
Website http://www.azm.nl
ROR logo "ROR" https://ror.org/02d9ce178

Funders

Funder type

University/education

University Hospital Maastricht (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

14/09/2017: Publication reference added.