NCT00175448

Brief Summary

A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home Exercise Program Following Discharge Home from Total Hip Arthroplasty

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2005

Enrollment Period

2.2 years

First QC Date

September 11, 2005

Last Update Submit

September 24, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical function at 16 weeks post THA in patients who received outpatient physiotherapy following discharge home compared to unsupervised self- directed exercises alone (as measured by the WOMAC).

    16 weeks

Secondary Outcomes (10)

  • Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA?

    2 years

  • Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in:

  • generic health-related QOL (SF-36) and (HUI3)

  • pain and stiffness (WOMAC pain and stiffness)

  • activities of daily living (FSI)

  • +5 more secondary outcomes

Interventions

physiotherapyPROCEDURE

See Detailed Description.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary THA (cemented or cementless)
  • preoperative diagnosis of osteoarthritis (primary or secondary)
  • meets objective discharge-to-home test following hip replacement
  • ability to speak English and reply to questionnaires written in English
  • ability to provide informed consent
  • may include patients presenting for their second primary hip arthroplasty
  • Discharge to Home Criteria
  • independent supine-to-sit transfer
  • independent sit-to-stand transfer
  • walk with walking aid 30 meters
  • ascend and descend 3 stairs
  • deemed medically fit and safe for home environment by surgeon/nursing/PT

You may not qualify if:

  • surgery as part of a workers' compensation claim
  • arthroplasty performed for trauma or following open reduction and internal fixation, malignancy or inflammatory arthropathy
  • intra-operative complication of fracture or sciatic nerve injury
  • procedure requiring complex surgical approach other than posterior or anterolateral (ie trochanteric osteotomy/micro 2 incision approach)
  • indications for additional primary or revision arthroplasty within the time frame of the study (24 months) in other hip or knee joints which would adversely affect quality of life and functional scores pertaining to the joint of interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Nelson Greidanus, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 25, 2008

Record last verified: 2005-09