OsteoarthritisNCT00878358
Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR
A study testing Hydrotherapy and Physiotherapy in people with Osteoarthritis and Total Knee Replacement, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Total Knee Replacement
- What is being tested?
- Hydrotherapy and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for first total knee replacement surgery.
- Age over 18.
- Diagnosed with Osteoarthritis.
- Consent to participate in the trial.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoarthritis, Total Knee Replacement
- Being tested
- Hydrotherapy, Physiotherapy
- Keywords
- Osteoarthritis, Total knee replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrotherapyOther
PhysiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Active comparator | Not described Receives: Other: Physiotherapy |
| Hydrotherapy | Experimental | Not described Receives: Other: Hydrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go test
Measured: 6 weeks
Secondary outcomes (3)
Oxford knee score
Measured: 6 weeks
Visual analogue pain score
Measured: 6 weeks
Range of knee motion
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878358
- Sponsor's protocol ID
- Hydrotherapy-HMO-CTIL
- Status last verified
- Apr 2009
- First submitted
- 7 Apr 2009
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR
- ClinicalTrials.gov ID
- NCT00878358
- Acronym / sponsor ID
- Hydrotherapy-HMO-CTIL
- Conditions
- Osteoarthritis, Total Knee Replacement
- Keywords
- Osteoarthritis, Total knee replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Active comparator | Other: Physiotherapy |
| Hydrotherapy | Experimental | Other: Hydrotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidates for first total knee replacement surgery.
Key exclusion criteria (8 listed)
- - Rheumatic diseases.
- Neurological diseases involving lower limbs.
- Prior knee surgery in operated knee.
- Secreting surgical wound.
- Skin diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrotherapy | Other | Hydrotherapy |
| Physiotherapy | Other | Physiotherapy |
Primary outcome
Timed up and go test
Time frame: 6 weeks
3 secondary outcomes
Oxford knee score
Time frame: 6 weeks
Visual analogue pain score
Time frame: 6 weeks
Range of knee motion
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrotherapy and Physiotherapy in people with Osteoarthritis and Total Knee Replacement, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go test (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2011.