OsteoarthritisNCT01797003
Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
A study testing High tibial osteotomy in people with Osteoarthritis, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis. Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- High tibial osteotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2007to Jan 2017
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medial osteoarthritis in the knee (x-ray and arthroscopy)
- Pain in medial compartment of the knee
- Correction angle of 5 degrees or more
Who cannot join
- Former or active infection in the knee
- Rheumatoid arthritis or other similar disease
- Cancer
- Neurological disease
- Kidney disease or metabolic disease
Trial locations and contacts
1 site in 1 country.
About this study
Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis.
Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.
Read the detailed description
Determination of the time course of patient-relevant functional outcome and the time course of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge methods.
Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients.
In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.
- Conditions
- Osteoarthritis
- Being tested
- High tibial osteotomy
- Keywords
- osteoarthritis, osteotomy, closing, opening, wedge, kne, tibia
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tibial osteotomyOther
| Study group | Role | What they receive |
|---|---|---|
| Opening wedge HTO | Active comparator | Opening wedge high tibial osteotomy using Puddu plate Receives: Other: High tibial osteotomy |
| Closing wedge HTO | Active comparator | Closing wedge high tibial osteotomy using cramp fixation Receives: Other: High tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kne injury and Osteoarthritis Outcome Score (KOOS)
The change in KOOS score are followed at several time points the first 2 years. Patients will be evaluated with KOOS, 3 months, 6 months, 1 year and 2 years postoperatively.
Measured: 2 years postoperataively
Secondary outcomes (1)
Range of motion (ROM)
The change in ROM are followed at several time points the first 2 years. ROM will be measured 3 months, 6 months, 1 year and 2 years postoperatively.
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMar 2007
- Primary completionJan 2017
- Study completionJan 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Tor Kjetil Nerhus, Vestre Viken Hospital Trust
- Investigators
- Tor Kjetil Nerhus, MD, Principal investigator, Consultant orthopaedic surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797003
- Sponsor's protocol ID
- TKN-003
- Status last verified
- Oct 2022
- First submitted
- 20 Feb 2013
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
- ClinicalTrials.gov ID
- NCT01797003
- Acronym / sponsor ID
- TKN-003
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, osteotomy, closing, opening, wedge, kne, tibia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- Mar 2007
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Feb 2013 (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.
Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis.
Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.
Detailed description
Determination of the time course of patient-relevant functional outcome and the time course of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge methods.
Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients.
In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opening wedge HTO | Active comparator | Other: High tibial osteotomyOpening wedge high tibial osteotomy using Puddu plate |
| Closing wedge HTO | Active comparator | Other: High tibial osteotomyClosing wedge high tibial osteotomy using cramp fixation |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medial osteoarthritis in the knee (x-ray and arthroscopy)
- Pain in medial compartment of the knee
- Correction angle of 5 degrees or more
Key exclusion criteria (5 listed)
- Former or active infection in the knee
- Rheumatoid arthritis or other similar disease
- Cancer
- Neurological disease
- Kidney disease or metabolic disease
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 |
|---|---|---|
| High tibial osteotomy | Other | Closing wedge HTO, Opening wedge HTO |
Primary outcome
Kne injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 2 years postoperataively
The change in KOOS score are followed at several time points the first 2 years. Patients will be evaluated with KOOS, 3 months, 6 months, 1 year and 2 years postoperatively.
1 secondary outcome
Range of motion (ROM)
Time frame: 2 years postoperatively
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 18 Oct 2022.
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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.
Tor Kjetil Nerhus, MD principal investigator
Consultant orthopaedic surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High tibial osteotomy in people with Osteoarthritis, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 5 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 18 Oct 2022. 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 Norway. 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?
Kne injury and Osteoarthritis Outcome Score (KOOS) (time frame: 2 years postoperataively). 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 18 Oct 2022.