Investigate the Change in the Weight-bearing-line (WBL) Ratio of the Ankle Joint and Ankle Joint Line Orientation After HTONCT05183750
Ankle Pain and Orientation After High Tibial Osteotomy as a Treatment of Medial Compartment Knee Osteoarthritis
A study testing High tibial osteotomy in people with Investigate the Change in the Weight-bearing-line (WBL) Ratio of the Ankle Joint and Ankle Joint Line Orientation After HTO, run by Sohag University at 1 site in Egypt.
Trial summary
Changes in demographics and physical activities of the young population have increased the number of patients with medial unicompartmental knee osteoarthritis (OA) requiring surgical intervention. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Investigate the Change in the Weight-bearing-line (WBL) Ratio of the Ankle Joint and Ankle Joint Line Orientation After HTO
- What is being tested?
- High tibial osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 15 Sep 2025
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic medial unicompartment knee arthritis
- Active patients younger than 55 years
- Good range of motion (ROM) .
- Intact lateral compartment
Who cannot join
- Combined medial and lateral arthrosis.
- Markedly decreased knee range of motion (arc of motion 10°).
- Ligamentous instability.
- Severe joint destruction (≥Ahlback grade III).
- ≥55 years of age.
- Advanced patellofemoral arthritis.
Show all 9Show fewer
- Rheumatoid arthritis.
- Structural lower extremity deformities.
- Previous operation at knee joint.
Trial locations and contacts
1 site in 1 country.
About this study
Changes in demographics and physical activities of the young population have increased the number of patients with medial unicompartmental knee osteoarthritis (OA) requiring surgical intervention.
High tibial osteotomy (HTO) have shown good clinical results in restoring lower extremity alignment, reducing pain, and improving knee function in patients with moderate-to-severe knee osteoarthritis and genu varum deformity.
The aim of this study is to evaluate the relation between correction of the malalignment of the knee and ankle pain and orientation in patient of medial compartment knee osteoarthritis using high tibial osteotomy by recent reports concerning the indications, functional outcomes and complication.
Read the detailed description
Knee osteoarthritis (OA) is highly prevalent worldwide. It is a leading cause of musculoskeletal disability and associated with activity limitation, working disability and reduced quality of life.
Osteoarthritis can affect any synovial joint in the body, however it occurs most often in weight-bearing joints, with the knee being one of the most commonly affected. Progressive loss of hyaline articular cartilage is often considered the hallmark of the disease. Within the tibiofemoral joint; articular cartilage degradation is most prevalent in the medial compartment.
Changes in demographics and physical activities of the young population have increased the number of patients with medial unicompartmental knee osteoarthritis (OA) requiring surgical intervention.
High tibial osteotomy (HTO) have shown good clinical results in restoring lower extremity alignment, reducing pain, and improving knee function in patients with moderate-to-severe knee osteoarthritis and genu varum deformity.
Prior to the development of total knee arthroplasty (TKA) as a reliable procedure in the 1980s, high tibial osteotomy (HTO) was the most common surgical treatment for varus gonarthrosis.
HTO may influence the alignment and function of the ankle joint. In the case of greater varus deformity where the preoperative talar tilt was increased medial to the ankle or the postoperative correction angle was large, the incidence of arthritis in the ankle joint rose Therefore, it is possible for realignment procedures in the knee HTO to affect ankle joint alignment and ankle symptoms.
Assessment of change in the weight-bearing-line (WBL) ratio of the ankle joints would provide a theoretical basis for post-operative ankle joint pain and osteoarthritis progression after knee arthroplasty or HTO.
The aim of this study is to evaluate the relation between correction of the malalignment of the knee and ankle pain and orientation in patient of medial compartment knee osteoarthritis using high tibial osteotomy by recent reports concerning the indications, functional outcomes and complication .
So this study aimed to investigate the change in the weight-bearing-line (WBL) ratio of the ankle joint and ankle joint line orientation after HTO in patients with genu varum deformity.
- Being tested
- High tibial osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tibial osteotomyProcedure or surgery
Opening wedge high tibial osteotomy will be done according to the measurement preoperatively and fixation will be by plate and screws.
| Study group | Role | What they receive |
|---|---|---|
| Adult with isolated medial compartmental knee osteoarthtitis | Other | Not described Receives: Procedure: High tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle pain (visual analogue score)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores represents a continuum between no pain 0 and worst pain 10.
Measured: 1year post operative follow up
Coronal alignment of the ankle
Tibial plafond inclination (TPI) (2) Talar inclination (TI) (3) Talar tilt (TT)and (4) Lateral distal tibial angle (LDTA)
Measured: 1year post operative follow up
coronal plane correction
hip-knee-ankle (HKA) angle, medial proximal tibial angle (MPTA), and knee-tibial plafond angle (KTPA)
Measured: 1year post operative follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Dec 2021
- Primary completion10 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Investigate the Change in the Weight-bearing-line (WBL) Ratio of the Ankle Joint and Ankle Joint Line Orientation After HTOStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Lotfy Saber Mohammed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183750
- Sponsor's protocol ID
- Soh-Med-21-12-18
- Status last verified
- Sep 2025
- First submitted
- 17 Dec 2021
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kijowski R, Blankenbaker D, Stanton P, Fine J, De Smet A. Arthroscopic validation of radiographic grading scales of osteoarthritis of the tibiofemoral joint. AJR Am J Roentgenol. 2006 Sep;187(3):794-9. doi: 10.2214/AJR.05.1123.
PubMed 16928947Lee JH, Jeong BO. Radiologic changes of ankle joint after total knee arthroplasty. Foot Ankle Int. 2012 Dec;33(12):1087-92. doi: 10.3113/FAI.2012.1087.
PubMed 23199858Ducat A, Sariali E, Lebel B, Mertl P, Hernigou P, Flecher X, Zayni R, Bonnin M, Jalil R, Amzallag J, Rosset P, Servien E, Gaudot F, Judet T, Catonne Y. Posterior tibial slope changes after opening- and closing-wedge high tibial osteotomy: a comparative prospective multicenter study. Orthop Traumatol Surg Res. 2012 Feb;98(1):68-74. doi: 10.1016/j.otsr.2011.08.013. Epub 2012 Jan 12.
PubMed 22244250Gaasbeek R, Welsing R, Barink M, Verdonschot N, van Kampen A. The influence of open and closed high tibial osteotomy on dynamic patellar tracking: a biomechanical study. Knee Surg Sports Traumatol Arthrosc. 2007 Aug;15(8):978-84. doi: 10.1007/s00167-007-0305-0. Epub 2007 May 5.
PubMed 17483931JACKSON JP, WAUGH W. Tibial osteotomy for osteoarthritis of the knee. J Bone Joint Surg Br. 1961 Nov;43-B:746-51. doi: 10.1302/0301-620X.43B4.746. No abstract available.
PubMed 14036496Lustig S, Scholes CJ, Costa AJ, Coolican MJ, Parker DA. Different changes in slope between the medial and lateral tibial plateau after open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2013 Jan;21(1):32-8. doi: 10.1007/s00167-012-2229-6. Epub 2012 Oct 4.
PubMed 23052121
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Pain and Orientation After High Tibial Osteotomy as a Treatment of Medial Compartment Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05183750
- Acronym / sponsor ID
- Soh-Med-21-12-18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 11 Jan 2022 (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.
Changes in demographics and physical activities of the young population have increased the number of patients with medial unicompartmental knee osteoarthritis (OA) requiring surgical intervention.
High tibial osteotomy (HTO) have shown good clinical results in restoring lower extremity alignment, reducing pain, and improving knee function in patients with moderate-to-severe knee osteoarthritis and genu varum deformity.
The aim of this study is to evaluate the relation between correction of the malalignment of the knee and ankle pain and orientation in patient of medial compartment knee osteoarthritis using high tibial osteotomy by recent reports concerning the indications, functional outcomes and complication.
Detailed description
Knee osteoarthritis (OA) is highly prevalent worldwide. It is a leading cause of musculoskeletal disability and associated with activity limitation, working disability and reduced quality of life.
Osteoarthritis can affect any synovial joint in the body, however it occurs most often in weight-bearing joints, with the knee being one of the most commonly affected. Progressive loss of hyaline articular cartilage is often considered the hallmark of the disease. Within the tibiofemoral joint; articular cartilage degradation is most prevalent in the medial compartment.
Changes in demographics and physical activities of the young population have increased the number of patients with medial unicompartmental knee osteoarthritis (OA) requiring surgical intervention.
High tibial osteotomy (HTO) have shown good clinical results in restoring lower extremity alignment, reducing pain, and improving knee function in patients with moderate-to-severe knee osteoarthritis and genu varum deformity.
Prior to the development of total knee arthroplasty (TKA) as a reliable procedure in the 1980s, high tibial osteotomy (HTO) was the most common surgical treatment for varus gonarthrosis.
HTO may influence the alignment and function of the ankle joint. In the case of greater varus deformity where the preoperative talar tilt was increased medial to the ankle or the postoperative correction angle was large, the incidence of arthritis in the ankle joint rose Therefore, it is possible for realignment procedures in the knee HTO to affect ankle joint alignment and ankle symptoms.
Assessment of change in the weight-bearing-line (WBL) ratio of the ankle joints would provide a theoretical basis for post-operative ankle joint pain and osteoarthritis progression after knee arthroplasty or HTO.
The aim of this study is to evaluate the relation between correction of the malalignment of the knee and ankle pain and orientation in patient of medial compartment knee osteoarthritis using high tibial osteotomy by recent reports concerning the indications, functional outcomes and complication .
So this study aimed to investigate the change in the weight-bearing-line (WBL) ratio of the ankle joint and ankle joint line orientation after HTO in patients with genu varum deformity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult with isolated medial compartmental knee osteoarthtitis | Other | Procedure: High tibial osteotomy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Symptomatic medial unicompartment knee arthritis
- Active patients younger than 55 years
- Good range of motion (ROM) .
- Intact lateral compartment
Key exclusion criteria (9 listed)
- Combined medial and lateral arthrosis.
- Markedly decreased knee range of motion (arc of motion 10°).
- Ligamentous instability.
- Severe joint destruction (≥Ahlback grade III).
- ≥55 years of age.
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 osteotomyOpening wedge high tibial osteotomy will be done according to the measurement preoperatively and fixation will be by plate and screws. | Procedure or surgery | Adult with isolated medial compartmental knee osteoarthtitis |
Primary outcome
Ankle pain (visual analogue score)
Time frame: 1year post operative follow up
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores represents a continuum between no pain 0 and worst pain 10.
Coronal alignment of the ankle
Time frame: 1year post operative follow up
Tibial plafond inclination (TPI) (2) Talar inclination (TI) (3) Talar tilt (TT)and (4) Lateral distal tibial angle (LDTA)
coronal plane correction
Time frame: 1year post operative follow up
hip-knee-ankle (HKA) angle, medial proximal tibial angle (MPTA), and knee-tibial plafond angle (KTPA)
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 23 Sep 2025.
- Background: PubMed 16928947Kijowski R, Blankenbaker D, Stanton P, Fine J, De Smet A. Arthroscopic validation of radiographic grading scales of osteoarthritis of the tibiofemoral joint. AJR Am J Roentgenol. 2006 Sep;187(3):794-9. doi: 10.2214/AJR.05.1123.
- Background: PubMed 23199858Lee JH, Jeong BO. Radiologic changes of ankle joint after total knee arthroplasty. Foot Ankle Int. 2012 Dec;33(12):1087-92. doi: 10.3113/FAI.2012.1087.
- Background: PubMed 22244250Ducat A, Sariali E, Lebel B, Mertl P, Hernigou P, Flecher X, Zayni R, Bonnin M, Jalil R, Amzallag J, Rosset P, Servien E, Gaudot F, Judet T, Catonne Y. Posterior tibial slope changes after opening- and closing-wedge high tibial osteotomy: a comparative prospective multicenter study. Orthop Traumatol Surg Res. 2012 Feb;98(1):68-74. doi: 10.1016/j.otsr.2011.08.013. Epub 2012 Jan 12.
- Background: PubMed 17483931Gaasbeek R, Welsing R, Barink M, Verdonschot N, van Kampen A. The influence of open and closed high tibial osteotomy on dynamic patellar tracking: a biomechanical study. Knee Surg Sports Traumatol Arthrosc. 2007 Aug;15(8):978-84. doi: 10.1007/s00167-007-0305-0. Epub 2007 May 5.
- Background: PubMed 14036496JACKSON JP, WAUGH W. Tibial osteotomy for osteoarthritis of the knee. J Bone Joint Surg Br. 1961 Nov;43-B:746-51. doi: 10.1302/0301-620X.43B4.746. No abstract available.
- Background: PubMed 23052121Lustig S, Scholes CJ, Costa AJ, Coolican MJ, Parker DA. Different changes in slope between the medial and lateral tibial plateau after open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2013 Jan;21(1):32-8. doi: 10.1007/s00167-012-2229-6. Epub 2012 Oct 4.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Investigate the Change in the Weight-bearing-line (WBL) Ratio of the Ankle Joint and Ankle Joint Line Orientation After HTO, run by Sohag University at 1 site in Egypt.
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 9 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 23 Sep 2025. 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 Egypt. 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?
Ankle pain (visual analogue score) (time frame: 1year post operative follow up). The study lists 3 primary outcomes in all. 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 NCT05183750, which also lists 6 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 23 Sep 2025.