Osteoarthritis, KneePhase 4NCT00426907
Weightbearing After High Tibial Osteotomy
A Phase 4 study testing Unlimited postoperative weightbearing in people with Osteoarthritis, Knee, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
In this project we want investigate the clinical results after different rehabilitation regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial Osteotomies. The hypothesis is that unlimited weightbearing is beneficial for the healing and rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Unlimited postoperative weightbearing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Sep 2014
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
- Varus deformity
Who cannot join
- Prednisolone treatment.
- NSAID treatment.
- BMI > or = 35.
- Previous surgery in lateral knee compartment.
- Secondary Arthrosis following fracture(s) of the tibial condyle(s).
- Lack of informed consent.
- Correction >12,5 mm
- Peroperative displaced fracture of lateral bony hinge.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital
Farsø, Northern Jutland
About this study
Official title: Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.
In this project we want investigate the clinical results after different rehabilitation regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial Osteotomies.
The hypothesis is that unlimited weightbearing is beneficial for the healing and rehabilitation.
Read the detailed description
In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.
However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.
Different rehabilitation-regimens are described, many advocating a period of partial weight-bearing for a period after surgery.
Results from biomechanical studies suggest that immediate full weight-bearing is safe, enabling earlier mobilisation without compromising safe solid healing.
The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies (osteosynthesis with the Dynafix® system (EBI)) after 2 different rehabilitation regimens: Limited weight-bearing (20 kg) for 6 weeks, and unrestricted weight-bearing.
The investigation is performed as a randomised prospective clinical trial including 20 patients with a planned 2 years follow-up period.
Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score.
Routine standing x-rays is performed. Stability of the osteotomy is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Unlimited postoperative weightbearing
- Keywords
- Osteoarthritis, Knee, Osteotomy, Healing, Rehabilitation, Roentgen Stereometric Analysis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unlimited postoperative weightbearingProcedure or surgery
Unlimited postoperative weightbearing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Full postoperative weightbearing Receives: Procedure: Unlimited postoperative weightbearing |
| 2 | Active comparator | Partial weightbearing 6 weeks postoperative Receives: Procedure: Unlimited postoperative weightbearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration in mm measured with RSA (Roentgen Stereometric Analysis):
Measured: Postoperative, at 3 month, 1 and 2 years.
Secondary outcomes (3)
Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative.
Measured: Postoperative, at 3 month, 1 and 2 years.
Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.
Measured: Postoperative, at 3 month, 1 and 2 years.
Bone Mineral Density (DEXA-scan) pre-op., Post.-op, at 6 weeks, 3 months and 1 and 2 years postop.
Measured: Postoperative, at 3 month, 1 and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Lind-Hansen, MD, Principal investigator, Orthopaedic Division, Northern Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426907
- Sponsor's protocol ID
- ON-04-016-TLH
- Status last verified
- Apr 2015
- First submitted
- 23 Jan 2007
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.
- ClinicalTrials.gov ID
- NCT00426907
- Acronym / sponsor ID
- ON-04-016-TLH
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Osteotomy, Healing, Rehabilitation, Roentgen Stereometric Analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jan 2007 (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.
In this project we want investigate the clinical results after different rehabilitation regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial Osteotomies.
The hypothesis is that unlimited weightbearing is beneficial for the healing and rehabilitation.
Detailed description
In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.
However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.
Different rehabilitation-regimens are described, many advocating a period of partial weight-bearing for a period after surgery.
Results from biomechanical studies suggest that immediate full weight-bearing is safe, enabling earlier mobilisation without compromising safe solid healing.
The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies (osteosynthesis with the Dynafix® system (EBI)) after 2 different rehabilitation regimens: Limited weight-bearing (20 kg) for 6 weeks, and unrestricted weight-bearing.
The investigation is performed as a randomised prospective clinical trial including 20 patients with a planned 2 years follow-up period.
Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score.
Routine standing x-rays is performed. Stability of the osteotomy is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Unlimited postoperative weightbearingFull postoperative weightbearing |
| 2 | Active comparator | Procedure: Unlimited postoperative weightbearingPartial weightbearing 6 weeks postoperative |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
- Varus deformity
Key exclusion criteria (8 listed)
- Prednisolone treatment.
- NSAID treatment.
- BMI > or = 35.
- Previous surgery in lateral knee compartment.
- Secondary Arthrosis following fracture(s) of the tibial condyle(s).
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 |
|---|---|---|
| Unlimited postoperative weightbearingUnlimited postoperative weightbearing | Procedure or surgery | 1, 2 |
Primary outcome
Migration in mm measured with RSA (Roentgen Stereometric Analysis):
Time frame: Postoperative, at 3 month, 1 and 2 years.
3 secondary outcomes
Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative.
Time frame: Postoperative, at 3 month, 1 and 2 years.
Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.
Time frame: Postoperative, at 3 month, 1 and 2 years.
Bone Mineral Density (DEXA-scan) pre-op., Post.-op, at 6 weeks, 3 months and 1 and 2 years postop.
Time frame: Postoperative, at 3 month, 1 and 2 years.
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 10 Apr 2015.
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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.
Thomas Lind-Hansen, MD principal investigator
Orthopaedic Division, Northern Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unlimited postoperative weightbearing in people with Osteoarthritis, Knee, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 3 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 10 Apr 2015. 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 Denmark. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Migration in mm measured with RSA (Roentgen Stereometric Analysis): (time frame: Postoperative, at 3 month, 1 and 2 years.). 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 10 Apr 2015; AzTrials last refreshed its copy on 1 Nov 2026.