NCT00878358

Brief Summary

Primary objective: To compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group. Secondary objectives: To compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group based on measurements of timed up and go (TUG, as primary outcome), range of motion, pain and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2009

Enrollment Period

10 months

First QC Date

April 7, 2009

Last Update Submit

April 27, 2011

Conditions

OsteoarthritisTotal Knee Replacement

Keywords

OsteoarthritisTotal knee replacement

Outcome Measures

Primary Outcomes (1)

  • Timed up and go test

    6 weeks

Secondary Outcomes (3)

  • Oxford knee score

    6 weeks

  • Visual analogue pain score

    6 weeks

  • Range of knee motion

    6 weeks

Study Arms (2)

Physiotherapy

ACTIVE COMPARATOR
Other: Physiotherapy

Hydrotherapy

EXPERIMENTAL
Other: Hydrotherapy

Interventions

HydrotherapyOTHER
Hydrotherapy
PhysiotherapyOTHER
Physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Candidates for first total knee replacement surgery.
  • Age over 18.
  • Diagnosed with Osteoarthritis.
  • Consent to participate in the trial.

You may not qualify if:

  • \- Rheumatic diseases.
  • Neurological diseases involving lower limbs.
  • Prior knee surgery in operated knee.
  • Secreting surgical wound.
  • Skin diseases.
  • Incontinence.
  • Incapable of signing informed consent.
  • Patients living outside Jerusalem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

HydrotherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2010

Study Completion

June 1, 2010

Last Updated

April 28, 2011

Record last verified: 2009-04

Locations

IL(1)