OsteoarthritisPhase 1/2NCT00266396
Weight-bearing Recommendation After Replacement of the Hip or Knee Joint
A Phase 1/2 study testing Recommend full weight-bearing and Recommend parital weight-bearing in people with Osteoarthritis, run by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein at 4 sites in Germany.
Trial summary
Despite the widespread use of total hip and knee arthroplasty, there is a notable lack of consensus regarding postoperative treatment, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Recommend full weight-bearing and Recommend parital weight-bearing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 4 sitesGermany
- Study dates
- Jan 2002to Jan 2007
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis for diagnosis of osteoarthritis or femoral head necrosis
Who cannot join
- A history of septic arthritis,
- Hip fracture,
- Intraoperative complications,
- History of implant surgery on the joint to be operated on,
- Rheumatoid arthritis,
- Amputations,
- Inability to complete the questionnaires because of cognitive or language difficulties.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Ostseeklinik Damp, Department I of Orthopedic Surgery
Damp, 24351
University of Schleswig-Holstein Medical Center, Kiel Campus
Kiel, 24105
University of Schleswig-Holstein Medical Center, Lübeck Campus
Lübeck, 23538
Wedel Hospital, Department of Surgery
Wedel, 22880
About this study
Official title: A Randomized Trial of Weight-bearing Recommendations After Total Hip or Total Knee Arthroplasty
Despite the widespread use of total hip and knee arthroplasty, there is a notable lack of consensus regarding postoperative treatment, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices. In particular, there are no evidence-based recommendations on the amount of weight that the patient should be advised to bear on the operated leg after the operation.
- Conditions
- Osteoarthritis
- Being tested
- Recommend full weight-bearing, Recommend parital weight-bearing
- Keywords
- Total Hip Arthroplasty, THA, Total Knee Arthroplasty, TKA, Total Hip Replacement, THR, Total Knee Replacement, TKR
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommend full weight-bearingBehavioural
The full weight-bearing group is trained in 4-point gait with crutches and is recommended to put as much weight as tolerated on the leg on which surgery has been performed, immediately after surgery
Recommend parital weight-bearingBehavioural
The partial weight-bearing group is trained in 3-point gait with crutches and is instructed to limit weight-bearing of the affected leg to 20kg for a period of six-weeks. Scales are used to train these participants not to exceed 20kg
| Study group | Role | What they receive |
|---|---|---|
| weight-bearing recommendation | Experimental | Weight-bearing recommendation after THA and TKA Receives: Behavioral: Recommend full weight-bearing; Behavioral: Recommend parital weight-bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index
Measured: Baseline, 3, 6, 12 and 24-months after surgery
Secondary outcomes (5)
Leg specific stiffness and pain, both measured by the WOMAC.
Measured: Baseline, 3, 6, 12 and 24-months after surgery
Physical component summary of the SF-36
Measured: Baseline, 3, 6, 12 and 24-months after surgery
Lequesne Hip resp. Knee Score
Measured: Baseline, 3, 6, 12 and 24-months after surgery
Patient satisfaction
Measured: Baseline, 3, 6, 12 and 24-months after surgery
Quality-Adjusted Life Years
Measured: Baseline, 3, 6, 12 and 24-months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startJan 2002
- Primary completionJan 2007
- Study completionJan 2007
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants
Sponsor and investigators
- Lead sponsor
- Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V, Landesversicherungsanstalt Schleswig-Holstein, Landesversicherungsanstalt Freie und Hansestadt Hamburg, Deutsche Arthrose-Hilfe
- Responsible party
- Principal investigator, Thoralf R Liebs, University Hospital Schleswig-Holstein
- Investigators
- Thoralf R Liebs, MD, Principal investigator, University of Schleswig-Holstein Medical Center, Kiel Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266396
- Sponsor's protocol ID
- vffr-35
- Status last verified
- Apr 2016
- First submitted
- 15 Dec 2005
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Weight-bearing Recommendations After Total Hip or Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00266396
- Acronym / sponsor ID
- vffr-35
- Conditions
- Osteoarthritis
- Keywords
- Total Hip Arthroplasty, THA, Total Knee Arthroplasty, TKA, Total Hip Replacement, THR, Total Knee Replacement, TKR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants
- Lead sponsor
- Verein zur Förderung der Rehabilitationsforschung in Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V, Landesversicherungsanstalt Schleswig-Holstein, Landesversicherungsanstalt Freie und Hansestadt Hamburg, Deutsche Arthrose-Hilfe
- Study start
- Jan 2002
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 16 Dec 2005 (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.
Despite the widespread use of total hip and knee arthroplasty, there is a notable lack of consensus regarding postoperative treatment, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices. In particular, there are no evidence-based recommendations on the amount of weight that the patient should be advised to bear on the operated leg after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| weight-bearing recommendation | Experimental | Behavioral: Recommend full weight-bearing, Behavioral: Recommend parital weight-bearingWeight-bearing recommendation after THA and TKA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis for diagnosis of osteoarthritis or femoral head necrosis
Key exclusion criteria (7 listed)
- A history of septic arthritis,
- Hip fracture,
- Intraoperative complications,
- History of implant surgery on the joint to be operated on,
- Rheumatoid arthritis,
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 |
|---|---|---|
| Recommend full weight-bearingThe full weight-bearing group is trained in 4-point gait with crutches and is recommended to put as much weight as tolerated on the leg on which surgery has been performed, immediately after surgery | Behavioural | weight-bearing recommendation |
| Recommend parital weight-bearingThe partial weight-bearing group is trained in 3-point gait with crutches and is instructed to limit weight-bearing of the affected leg to 20kg for a period of six-weeks. Scales are used to train these participants not to exceed 20kg | Behavioural | weight-bearing recommendation |
Primary outcome
Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index
Time frame: Baseline, 3, 6, 12 and 24-months after surgery
5 secondary outcomes
Leg specific stiffness and pain, both measured by the WOMAC.
Time frame: Baseline, 3, 6, 12 and 24-months after surgery
Physical component summary of the SF-36
Time frame: Baseline, 3, 6, 12 and 24-months after surgery
Lequesne Hip resp. Knee Score
Time frame: Baseline, 3, 6, 12 and 24-months after surgery
Patient satisfaction
Time frame: Baseline, 3, 6, 12 and 24-months after surgery
Quality-Adjusted Life Years
Time frame: Baseline, 3, 6, 12 and 24-months after surgery
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 6 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Thoralf R Liebs, MD principal investigator
University of Schleswig-Holstein Medical Center, Kiel Campus
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recommend full weight-bearing and Recommend parital weight-bearing in people with Osteoarthritis, run by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein at 4 sites in Germany.
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 1 inclusion and 7 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 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index (time frame: Baseline, 3, 6, 12 and 24-months after surgery). 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 6 Apr 2016.