Condition category
Surgery
Date applied
26/08/2005
Date assigned
07/09/2005
Last edited
10/09/2009
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

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

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

2006 results in ://www.ncbi.nlm.nih.gov/pubmed/16942627

Publication citations

  1. 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.

Additional files

Editorial Notes