Osteoarthritis, KneeNCT00799370
Randomized Control Trial on Postoperative Weight Bearing After High Tibial Osteotomy (HTO)
A study testing Early weight bearing and Delayed weight bearing in people with Osteoarthritis, Knee, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The study analyzes the consequences of weight bearing after an HTO in a population of young patient with medial osteoarthritis (immediate weight bearing versus two month weight bearing). The two options are usually used so the protocol belongs to the intermediate care evaluation category. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Early weight bearing and Delayed weight bearing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Mar 2014
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 40 to 65 years old
- patients with medial osteoarthritis of knee of level 1 or 2 from ahlback's classification with High Tibial Osteotomy indication
- one sided indication
- well understanding of information note by patient, non-opposition to perform the research
- Affiliation to a national health insurance program
Who cannot join
- age < 40 or > 65 years old
- medial osteoarthritis of knee of level superior to 2
- bilatéral indication
- patient opposition
- non affiliation to a national health insurance program
- law protected patients
- pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study on Postoperative Weight Bearing After Opening Wedge High Tibial Osteotomy (HTO): Early Weight Bearing Versus Delayed. Open Labelled Randomized Clinical Study
The study analyzes the consequences of weight bearing after an HTO in a population of young patient with medial osteoarthritis (immediate weight bearing versus two month weight bearing). The two options are usually used so the protocol belongs to the intermediate care evaluation category.
The IKS (International Knee Society) score at one year follow up is the first outcome. The aim of the study is to highlight that the option early weight bearing (immediately in postoperative) is equal to the option delayed weight bearing.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Early weight bearing, Delayed weight bearing
- Keywords
- Osteotomy, Weight bearing, Opening wedge
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early weight bearingProcedure or surgery
Weight bearing performed immediately after surgery
Delayed weight bearingProcedure or surgery
Weight bearing performed 2 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Early weight bearing: immediate in postoperative Receives: Procedure: Early weight bearing |
| 2 | Experimental | Delayed weight bearing: 2 months after surgery Receives: Procedure: Delayed weight bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKS score
Measured: one year follow-up
Secondary outcomes (4)
IKS score
Measured: 6 months follow-up
VAS score of pain
Measured: at D1, D5, D15, M1, M2, M3, M6 and one year follow-up
IKDC (International Knee Documentation Committee) score
Measured: at M2, M, M6 and one year follow-up
Safety follow-up
Measured: during the one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elvire SERVIEN, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799370
- Sponsor's protocol ID
- 2007.477
- Status last verified
- Jun 2014
- First submitted
- 25 Nov 2008
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Lansdaal JR, Mouton T, Wascher DC, Demey G, Lustig S, Neyret P, Servien E. Early weight bearing versus delayed weight bearing in medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Dec;25(12):3670-3678. doi: 10.1007/s00167-016-4225-8. Epub 2016 Jul 1.
PubMed 27371292
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Postoperative Weight Bearing After Opening Wedge High Tibial Osteotomy (HTO): Early Weight Bearing Versus Delayed. Open Labelled Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT00799370
- Acronym / sponsor ID
- 2007.477
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteotomy, Weight bearing, Opening wedge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Nov 2008 (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.
The study analyzes the consequences of weight bearing after an HTO in a population of young patient with medial osteoarthritis (immediate weight bearing versus two month weight bearing). The two options are usually used so the protocol belongs to the intermediate care evaluation category.
The IKS (International Knee Society) score at one year follow up is the first outcome. The aim of the study is to highlight that the option early weight bearing (immediately in postoperative) is equal to the option delayed weight bearing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Early weight bearingEarly weight bearing: immediate in postoperative |
| 2 | Experimental | Procedure: Delayed weight bearingDelayed weight bearing: 2 months after surgery |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age: 40 to 65 years old
- patients with medial osteoarthritis of knee of level 1 or 2 from ahlback's classification with High Tibial Osteotomy indication
- one sided indication
- well understanding of information note by patient, non-opposition to perform the research
- Affiliation to a national health insurance program
Key exclusion criteria (7 listed)
- age < 40 or > 65 years old
- medial osteoarthritis of knee of level superior to 2
- bilatéral indication
- patient opposition
- non affiliation to a national health insurance program
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 |
|---|---|---|
| Early weight bearingWeight bearing performed immediately after surgery | Procedure or surgery | 1 |
| Delayed weight bearingWeight bearing performed 2 months after surgery | Procedure or surgery | 2 |
Primary outcome
IKS score
Time frame: one year follow-up
4 secondary outcomes
IKS score
Time frame: 6 months follow-up
VAS score of pain
Time frame: at D1, D5, D15, M1, M2, M3, M6 and one year follow-up
IKDC (International Knee Documentation Committee) score
Time frame: at M2, M, M6 and one year follow-up
Safety follow-up
Time frame: during the one year follow-up
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 May 2019.
- Results publication: PubMed 27371292Lansdaal JR, Mouton T, Wascher DC, Demey G, Lustig S, Neyret P, Servien E. Early weight bearing versus delayed weight bearing in medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Dec;25(12):3670-3678. doi: 10.1007/s00167-016-4225-8. Epub 2016 Jul 1.
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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.
Elvire SERVIEN, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early weight bearing and Delayed weight bearing in people with Osteoarthritis, Knee, run by Hospices Civils de Lyon at 1 site in France.
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 5 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 28 May 2019. 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 France. 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?
IKS score (time frame: one year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00799370, which also lists 1 linked publication.
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 May 2019.