Osteo Arthritis KneeNCT04036266
Clinical and Radiographic Outcomes of Medial Open-wedge High Tibial Osteotomy
An observational study of Osteo Arthritis Knee, run by Assiut University.
Trial summary
Osteoarthritis is a common degenerative disorder of the articular cartilage . Risk factors include genetics, female sex, past trauma, advancing age, and obesity. The diagnosis is based on a history of joint pain worsened by movement, which can lead to disability in activities of daily living . Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- medial open wedge high tibial osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Dec 2020
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients older than 30 years old that underwent medial open wedge high tibial osteotomy due to medial osteoarthritis of the knee
Who may be able to join
- Age above 30 years old.
- Patients who had MOWHTO for knee OA within the past 5 years .
- No response to non-surgical treatment (medical and physiotherapy) pre operatively for at least 3 months.
- Intact cruciate ligaments, and Collateral ligaments.
Who cannot join
- Age less than 30 years old.
- Patients who had HTO for another reasons other than knee OA.
- Combined injury to (collateral ligaments, cruciate ligament).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Medial Open Wedge High Tibial Osteotomy on Clinical and Radiographic Outcomes of Patients With Knee Osteoarthritis : A Retrospective Study
Osteoarthritis is a common degenerative disorder of the articular cartilage . Risk factors include genetics, female sex, past trauma, advancing age, and obesity. The diagnosis is based on a history of joint pain worsened by movement, which can lead to disability in activities of daily living .
Diagnosis of knee osteoarthritis can be confirmed based on clinical and/or radiological features. The potential of a progressive disease can be prevented or decreased by earlier recognition and correction of associated factors. Obesity and alignment especially varus malalignment are recognized factors of a progressive disease.
Read more
High tibial osteotomy (HTO) is a widely performed procedure, and good results can be achieved with appropriate patient selection and precise surgical technique. It is reported to be an effective treatment for varus knee osteoarthritis (OA) by redistributing the load line within the knee joint . With an HTO, the surgeon aims to change the coronal alignment of the leg in order to shift the center of force passing axially through the knee from the arthritic region of the knee towards the unaffected side. The amount of alignment correction to be performed is calculated before surgery based on the extent of knee arthrosis and on the alignment of the patient's lower limbs on long-leg weight bearing radiographs .
Our study is focused on effectiveness of open wedge High tibial osteotomy on clinical and radiographic outcomes of patients with medial knee osteoarthritis.
Read the detailed description
The investigators will conduct a retrospective case-series study of at least 40 patients , who underwent medial open-wedge HTO for treatment of medial knee osteoarthritis between January 2016 and January 2019 in our Arthroscopy and Sports Injuries Unit in Orthopaedics Department of Assiut University. Inclusion criteria is Kellgren-Lawrence classification grades 1 to 3; symptomatic unicompartmental osteoarthritis
Pre-operative :
assessment of patients is done clinically using Knee society score (KSS) and visual analogue scale (VAS) (0 mm, no pain;100 mm, worst pain) and radiographic assessment according to Kellgren and Lawrence using anteroposterior (AP) and lateral x-ray views of the knee , a two-leg long standing view with or without slight flexion assessing Femoral-tibial angle (FTA) .
Intra-operative :
After anaesthesia is induced, an arthroscopic examination is performed to define the status of the menisci (excluding significant damage of the lateral compartment), cruciate ligaments, and articular cartilage. meniscal surgery (partial menisectomy/meniscal repair) is performed when necessary, then The medial open wedge high tibial osteotomy (MOWHTO) is performed.
Post-operative :
follow up after at least 1 year post-operative clinically using knee society score (KSS) , visual analogue scale (VAS),Knee Injury and Osteoarthritis Outcome Score(KOOS) , Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index scores and radiological assessment using Anteroposterior and lateral views xrays assessing union two-leg long standing view x ray with or without slight flexion assessing Femoral-tibial angle (FTA) and joint line .
- Conditions
- Osteo Arthritis Knee
- Being tested
- medial open wedge high tibial osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medial open wedge high tibial osteotomyProcedure or surgery
opening of medial aspects of the proximal tibial metaphysis and change the coronal alignment of the tibia in order to shift the center of force passing axially through the knee from the arthritic region of the knee towards the unaffected side then fixation with a plate (the standard plate is the T-locked plate )
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief is being assessed using Visual analogue scale (VAS)
assessment is done using Visual analogue scale (VAS)
Measured: 1 year up to 5 years post operative
Secondary outcomes (1)
varus malalignment correction of the knee
this is measured using femoral tibial angle
Measured: 1 year up to 5 years post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah Abdelhamid Ahmed, Assiut University
- Investigators
- Mohamed M. Abdelhamid, PHD, Study chair, Professor of Orthopedics and TraumatologyIslam K. Ramadan, PHD, Study director, Lecturer of Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036266
- Sponsor's protocol ID
- MOWHTO in OA
- Status last verified
- Sep 2019
- First submitted
- 29 Mar 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heidari B. Knee osteoarthritis diagnosis, treatment and associated factors of progression: part II. Caspian J Intern Med. 2011 Summer;2(3):249-55.
PubMed 24049581Kim YS, Koh YG. Comparative Matched-Pair Analysis of Open-Wedge High Tibial Osteotomy With Versus Without an Injection of Adipose-Derived Mesenchymal Stem Cells for Varus Knee Osteoarthritis: Clinical and Second-Look Arthroscopic Results. Am J Sports Med. 2018 Sep;46(11):2669-2677. doi: 10.1177/0363546518785973. Epub 2018 Aug 6.
PubMed 30080423Mukherjee K, Latif A, Ranjan AK, Dugar N. High tibial osteotomy--an effective treatment option for osteo-arthritis. J Indian Med Assoc. 2013 Dec;111(12):801-3.
PubMed 25154146Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012 Jan 1;85(1):49-56.
PubMed 22230308Altay MA, Erturk C, Altay N, Mercan AS, Sipahioglu S, Kalender AM, Isikan UE. Clinical and radiographic outcomes of medial open-wedge high tibial osteotomy with Anthony-K plate: prospective minimum five year follow-up data. Int Orthop. 2016 Jul;40(7):1447-54. doi: 10.1007/s00264-015-2919-z. Epub 2015 Jul 21.
PubMed 26194919
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medial Open Wedge High Tibial Osteotomy on Clinical and Radiographic Outcomes of Patients With Knee Osteoarthritis : A Retrospective Study
- ClinicalTrials.gov ID
- NCT04036266
- Acronym / sponsor ID
- MOWHTO in OA
- Conditions
- Osteo Arthritis Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 29 Jul 2019 (actual)
- 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.
Osteoarthritis is a common degenerative disorder of the articular cartilage . Risk factors include genetics, female sex, past trauma, advancing age, and obesity. The diagnosis is based on a history of joint pain worsened by movement, which can lead to disability in activities of daily living .
Diagnosis of knee osteoarthritis can be confirmed based on clinical and/or radiological features. The potential of a progressive disease can be prevented or decreased by earlier recognition and correction of associated factors. Obesity and alignment especially varus malalignment are recognized factors of a progressive disease.
High tibial osteotomy (HTO) is a widely performed procedure, and good results can be achieved with appropriate patient selection and precise surgical technique. It is reported to be an effective treatment for varus knee osteoarthritis (OA) by redistributing the load line within the knee joint . With an HTO, the surgeon aims to change the coronal alignment of the leg in order to shift the center of force passing axially through the knee from the arthritic region of the knee towards the unaffected side. The amount of alignment correction to be performed is calculated before surgery based on the extent of knee arthrosis and on the alignment of the patient's lower limbs on long-leg weight bearing radiographs .
Our study is focused on effectiveness of open wedge High tibial osteotomy on clinical and radiographic outcomes of patients with medial knee osteoarthritis.
Detailed description
The investigators will conduct a retrospective case-series study of at least 40 patients , who underwent medial open-wedge HTO for treatment of medial knee osteoarthritis between January 2016 and January 2019 in our Arthroscopy and Sports Injuries Unit in Orthopaedics Department of Assiut University. Inclusion criteria is Kellgren-Lawrence classification grades 1 to 3; symptomatic unicompartmental osteoarthritis
Pre-operative :
assessment of patients is done clinically using Knee society score (KSS) and visual analogue scale (VAS) (0 mm, no pain;100 mm, worst pain) and radiographic assessment according to Kellgren and Lawrence using anteroposterior (AP) and lateral x-ray views of the knee , a two-leg long standing view with or without slight flexion assessing Femoral-tibial angle (FTA) .
Intra-operative :
After anaesthesia is induced, an arthroscopic examination is performed to define the status of the menisci (excluding significant damage of the lateral compartment), cruciate ligaments, and articular cartilage. meniscal surgery (partial menisectomy/meniscal repair) is performed when necessary, then The medial open wedge high tibial osteotomy (MOWHTO) is performed.
Post-operative :
follow up after at least 1 year post-operative clinically using knee society score (KSS) , visual analogue scale (VAS),Knee Injury and Osteoarthritis Outcome Score(KOOS) , Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index scores and radiological assessment using Anteroposterior and lateral views xrays assessing union two-leg long standing view x ray with or without slight flexion assessing Femoral-tibial angle (FTA) and joint line .
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients older than 30 years old that underwent medial open wedge high tibial osteotomy due to medial osteoarthritis of the knee
Key inclusion criteria (4 listed)
- Age above 30 years old.
- Patients who had MOWHTO for knee OA within the past 5 years .
- No response to non-surgical treatment (medical and physiotherapy) pre operatively for at least 3 months.
- Intact cruciate ligaments, and Collateral ligaments.
Key exclusion criteria (3 listed)
- Age less than 30 years old.
- Patients who had HTO for another reasons other than knee OA.
- Combined injury to (collateral ligaments, cruciate ligament).
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 |
|---|---|---|
| medial open wedge high tibial osteotomyopening of medial aspects of the proximal tibial metaphysis and change the coronal alignment of the tibia in order to shift the center of force passing axially through the knee from the arthritic region of the knee towards the unaffected side then fixation with a plate (the standard plate is the T-locked plate ) | Procedure or surgery | – |
Primary outcome
pain relief is being assessed using Visual analogue scale (VAS)
Time frame: 1 year up to 5 years post operative
assessment is done using Visual analogue scale (VAS)
1 secondary outcome
varus malalignment correction of the knee
Time frame: 1 year up to 5 years post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Background: PubMed 24049581Heidari B. Knee osteoarthritis diagnosis, treatment and associated factors of progression: part II. Caspian J Intern Med. 2011 Summer;2(3):249-55.
- Background: PubMed 30080423Kim YS, Koh YG. Comparative Matched-Pair Analysis of Open-Wedge High Tibial Osteotomy With Versus Without an Injection of Adipose-Derived Mesenchymal Stem Cells for Varus Knee Osteoarthritis: Clinical and Second-Look Arthroscopic Results. Am J Sports Med. 2018 Sep;46(11):2669-2677. doi: 10.1177/0363546518785973. Epub 2018 Aug 6.
- Background: PubMed 25154146Mukherjee K, Latif A, Ranjan AK, Dugar N. High tibial osteotomy--an effective treatment option for osteo-arthritis. J Indian Med Assoc. 2013 Dec;111(12):801-3.
- Background: PubMed 22230308Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012 Jan 1;85(1):49-56.
- Background: PubMed 26194919Altay MA, Erturk C, Altay N, Mercan AS, Sipahioglu S, Kalender AM, Isikan UE. Clinical and radiographic outcomes of medial open-wedge high tibial osteotomy with Anthony-K plate: prospective minimum five year follow-up data. Int Orthop. 2016 Jul;40(7):1447-54. doi: 10.1007/s00264-015-2919-z. Epub 2015 Jul 21.
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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.
Mohamed M. Abdelhamid, PHD study chair
Professor of Orthopedics and Traumatology
Islam K. Ramadan, PHD study director
Lecturer of Orthopedics and Traumatology
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Knee, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S. Abdelhamid, MBBCh (+201033589233 ext. +201551411316, mohamedsalah.medic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief is being assessed using Visual analogue scale (VAS) (time frame: 1 year up to 5 years post operative). 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 NCT04036266, which also lists 5 linked publications.
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 17 Sep 2019.