Knee OsteoarthritisNCT07583264
Early Weight Bearing After Open Wedge High Tibial Osteotomy (OWHTO), Is it Worth?
A study testing Early weight bearing post operative and Non weight bearing Post-operative in people with Knee Osteoarthritis, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of our study is to evaluate the effect of early weight bearing after OWHTO on pain, function and return to normal lifestyle activity. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Early weight bearing post operative and Non weight bearing Post-operative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Mar 2024to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age from 15 to 60 years old.
- Medial compartmental knee OA.
- With or without medial meniscal injury.
- With or without Cartilage defect.
- Genu varus from 5-15 degrees .
- Flexion deformity < 10 degree .
Who cannot join
- Older than 50 years old and younger than 15 years old.
- Multiligament injury.
- Lateral compartmental knee OA > GII.
- Genu varus < 5 or > 15 degree .
- Flexion deformity > 10 degree .
- Associated ligamentous reconstruction.
Show all 10Show fewer
- Revision HTO.
- Meniscal root repair.
- Lateral meniscal injury.
- Mal-united Fr. Tibial plateau.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to evaluate the effect of early weight bearing after OWHTO on pain, function and return to normal lifestyle activity.
Read the detailed description
The management of medial compartment osteoarthritis of the knee in middle-aged patients is challenging. High tibial osteotomy (HTO) is a joint-preserving procedure that can relieve symptoms and return patients back to an active lifestyle. However, both total and uni-compartmental knee arthroplasty can provide good pain relief, but there is concern about the durability of the components in this younger population.
High tibial osteotomy (HTO) is a procedure with proven short-, medium- and long-term efficacy for treating isolated medial tibiofemoral knee osteoarthritis in young subjects with varus knee deformity.
Several studies have shown that the HTO lasts on average 10 years. After this, 74% to 96% of patients require total knee arthroplasty (TKA).
HTO can delay or sometime even avoid the need for arthroplasty. Better functional results have been seen in younger patients. HTO can also be performed to treat medial femoral condyle osteonecrosis or as part of the treatment of ligament injuries with varus malalignment.
The goal of high tibial osteotomy in knees with medial compartment OA is to shift the weight bearing axis from the medial compartment into the lateral compartment. This unloads the damaged medial articular cartilage. To achieve this, two main surgical techniques have been utilized, the lateral closing wedge and the medial opening wedge high tibial osteotomy (MOHTO). The lateral closing wedge HTO has the advantage of early bony healing at the osteotomy site.
- Conditions
- Knee Osteoarthritis
- Being tested
- Early weight bearing post operative, Non weight bearing Post-operative
- Keywords
- deformity correction, High tibial Osteotomy, Knee Arthroscopy, Knee Synovitis
- 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 bearing post operativeOther
this group underwent High tibial osteotomy and started early partial weight bearing post-operative at week 2 using crutches and restricted 20 kg of load for 4 weeks. Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation.
Non weight bearing Post-operativeOther
the group underwent High tibial osteotomy and started weight bearing post-operative at week 6. Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Early weight bearing group | Experimental | this group underwent High tibial osteotomy and started early partial weight bearing post-operative at week 2 using crutches. Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation. Receives: Other: Early weight bearing post operative |
| Non weight bearing group | Active comparator | this group underwent High tibial osteotomy and started weight bearing post-operative at week 6. Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation. this is a control group Receives: Other: Non weight bearing Post-operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
We used The nternational Knee Documentation Committee (IKDC) score as a validated, patient-reported outcome measure designed to quantify functional limitations, symptoms, and sports activity levels across a broad range of knee pathologies. IKDC scores are utilized to objectively assess a patient's ability to perform activities of daily living and to establish data-driven benchmarks for Return-to-Sport (RTS). Furthermore, by providing a longitudinal perspective on recovery, the scale allows us to monitor the progression of clinical improvement and determine the overall efficacy of surgical and rehabilitative interventions. The IKDC utilizes a normalized scale ranging from 0 to 100. A score of 0 represents the lowest possible level of function, indicating severe physical limitations and significant symptomatic distress. Conversely, a score of 100 represents the highest possible outcome, a total absence of symptoms and no limitations in either strenuous sports activities or daily living.
Measured: All patients of both groups underwent a clinical evaluation at 6-weeks, 3-months and 6-months post-operatively to assess knee range of motion and return to daily activity life.
Secondary outcomes (1)
Radiological outcome
Preoperative radiological evaluation of all patients included conventional radiography.
Assessment of group 1 was performed using weight-bearing standing radiographs to evaluate the degree of varus correction and screen for potential complications at 2-weeks, 6-weeks, 3-months and 6-months postoperative.
Assessment of group 2 was performed using weight-bearing standing radiographs and long film at 6-weeks, 3-months and 6-months postoperative.
Measured: Assessment of both groups was performed using weight-bearing standing radiographs to evaluate the degree of varus correction and screen for potential complications at 2-weeks (group1), 6-weeks, 3-months and 6-months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start8 Mar 2024
- Primary completion8 Mar 2025
- Study completion8 Jun 2026 (estimated)
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 Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-groups superiority randomized controlled blinded trial
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel-Tawab, Assiut University
- Investigators
- Hatem Galal Said, Professor, Study chair, Professor of orthopaedic and trauma surgery, Assiut UniversityMohamed Abdel Radi, Professor, Study director, Professor of orthopaedic and trauma surgery, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583264
- Sponsor's protocol ID
- High tibial Osteotomy in Knee
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Dean, C.S., et al., Clinical outcomes of high tibial osteotomy for knee instability: a systematic review. Orthopaedic journal of sports medicine, 2016. 4(3): p. 2325967116633419. 2. Gkekas, N.K., et al., Medial open wedge high tibial osteotomy is a viable option in young patients with advanced arthritis in a long-term follow-up. Knee Surgery, Sports Traumatology, Arthroscopy, 2025. 33(3): p. 1025-1032. 3. Kim, K.J., et al., Biomechanical study of the fixation plates for opening wedge high tibial osteotomy. Knee Surgery & Related Research, 2015. 27(3): p. 181. 4. Van Haeringen, M., et al., Opening-and closing-wedge high tibial osteotomy are comparable and early full weight bearing is safe with angular stable plate fixation: a meta-analysis. Knee Surgery, Sports Traumatology, Arthroscopy, 2023. 31(7): p. 3015-3026. 5. Lansdaal, J.R., et al., Early weight bearing versus delayed weight bearing in medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surgery, Sports Traumatology, Arthroscopy, 2017. 25(12): p. 3670-3678. 6. Jiang, Y., et al., Clinical and radiographic outcomes of double-triangle locking compression plate (DT-LCP) versus T-shaped locking compression plate (T-LCP) in medial open-wedge high tibial osteotomy: a follow-up study of over 5 years. Journal of Orthopaedic Surgery and Research, 2026. 21(1): p. 1. 7. Saad, R., et al., Six Weeks in Orthopedics: Biological Basis, Clinical Practice, and Evidence for a Universal Benchmark. Orthopedic Reviews, 2026. 18: p. 156461. 8. Elsenosy, A.M., et al., Early Versus Delayed Weight-Bearing Following Tibial Plateau Fracture Surgery: A Systematic Review and Meta-Analysis. Cureus, 2025. 17(10). 9. Higgins, L.D., et al., Reliability and validity of the International Knee Documentation Committee (IKDC) subjective knee form. Joint Bone Spine, 2007. 74(6): p. 594-599. 10. Collins, N., et al., Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis and cartilage, 2016. 24(8): p. 1317-1329. 11. Resch, T., et al., Open-wedge high tibial osteotomy with and without bone void filler: Allograft leads to faster bone union and weight bearing with comparable return to work and sports rates. Knee Surgery, Sports Traumatology, Arthroscopy, 2024. 32(7): p. 1785-1797. 12. Rocca, M.S., K. Dias, and J.D. Hughes, Joint preservation procedures: osteotomies about the knee. Annals of joint, 2025. 10: p. 17. 13. Azuma, T., et al., In-hospital grouping rehabilitation of hybrid closed-wedge high tibial osteotomy results in shorter hospital stays and better clinical outcomes. Journal of Physical Therapy Science, 2023. 35(8): p. 575-580. 14. Ueda, Y., et al., Knee extensor strength normalised to body weight is associated with patient-reported outcomes at 12 months after open-wedge high tibial osteotomy. Journal of Experimental Orthopaedics, 2026. 13(1): p. e70625. 15. Nha, K.-W., et al., Fixation stability and stress redistribution following metal block use in opening-wedge high tibial osteotomy: a finite element analysis. Frontiers in Bioengineering and Biotechnology, 2025. 13: p. 1703140. 16. Franulic, N., et al., Lateral hinge fracture in medial opening wedge high tibial osteotomy: a narrative review. EFORT Open Reviews, 2023. 8(7): p. 572-580.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weight Bearing After Open Wedge High Tibial Osteotomy (OWHTO), Is it Worth?
- ClinicalTrials.gov ID
- NCT07583264
- Acronym / sponsor ID
- High tibial Osteotomy in Knee
- Conditions
- Knee Osteoarthritis
- Keywords
- deformity correction, High tibial Osteotomy, Knee Arthroscopy, Knee Synovitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 8 Mar 2025 (actual)
- Study completion
- 8 Jun 2026 (estimated)
- First posted
- 13 May 2026 (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.
The aim of our study is to evaluate the effect of early weight bearing after OWHTO on pain, function and return to normal lifestyle activity.
Detailed description
The management of medial compartment osteoarthritis of the knee in middle-aged patients is challenging. High tibial osteotomy (HTO) is a joint-preserving procedure that can relieve symptoms and return patients back to an active lifestyle. However, both total and uni-compartmental knee arthroplasty can provide good pain relief, but there is concern about the durability of the components in this younger population.
High tibial osteotomy (HTO) is a procedure with proven short-, medium- and long-term efficacy for treating isolated medial tibiofemoral knee osteoarthritis in young subjects with varus knee deformity.
Several studies have shown that the HTO lasts on average 10 years. After this, 74% to 96% of patients require total knee arthroplasty (TKA).
HTO can delay or sometime even avoid the need for arthroplasty. Better functional results have been seen in younger patients. HTO can also be performed to treat medial femoral condyle osteonecrosis or as part of the treatment of ligament injuries with varus malalignment.
The goal of high tibial osteotomy in knees with medial compartment OA is to shift the weight bearing axis from the medial compartment into the lateral compartment. This unloads the damaged medial articular cartilage. To achieve this, two main surgical techniques have been utilized, the lateral closing wedge and the medial opening wedge high tibial osteotomy (MOHTO). The lateral closing wedge HTO has the advantage of early bony healing at the osteotomy site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel-groups superiority randomized controlled blinded trial
| Arm | Type | Receives |
|---|---|---|
| Early weight bearing group | Experimental | Other: Early weight bearing post operativethis group underwent High tibial osteotomy and started early partial weight bearing post-operative at week 2 using crutches. Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation. |
| Non weight bearing group | Active comparator | Other: Non weight bearing Post-operativethis group underwent High tibial osteotomy and started weight bearing post-operative at week 6. Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation. this is a control group |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age from 15 to 60 years old.
- Medial compartmental knee OA.
- With or without medial meniscal injury.
- With or without Cartilage defect.
- Genu varus from 5-15 degrees .
Key exclusion criteria (10 listed)
- Older than 50 years old and younger than 15 years old.
- Multiligament injury.
- Lateral compartmental knee OA > GII.
- Genu varus < 5 or > 15 degree .
- Flexion deformity > 10 degree .
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 bearing post operativethis group underwent High tibial osteotomy and started early partial weight bearing post-operative at week 2 using crutches and restricted 20 kg of load for 4 weeks. Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation. | Other | Early weight bearing group |
| Non weight bearing Post-operativethe group underwent High tibial osteotomy and started weight bearing post-operative at week 6. Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation. | Other | Non weight bearing group |
Primary outcome
Clinical outcome
Time frame: All patients of both groups underwent a clinical evaluation at 6-weeks, 3-months and 6-months post-operatively to assess knee range of motion and return to daily activity life.
We used The nternational Knee Documentation Committee (IKDC) score as a validated, patient-reported outcome measure designed to quantify functional limitations, symptoms, and sports activity levels across a broad range of knee pathologies. IKDC scores are utilized to objectively assess a patient's ability to perform activities of daily living and to establish data-driven benchmarks for Return-to-Sport (RTS). Furthermore, by providing a longitudinal perspective on recovery, the scale allows us to monitor the progression of clinical improvement and determine the overall efficacy of surgical and rehabilitative interventions. The IKDC utilizes a normalized scale ranging from 0 to 100. A score of 0 represents the lowest possible level of function, indicating severe physical limitations and significant symptomatic distress. Conversely, a score of 100 represents the highest possible outcome, a total absence of symptoms and no limitations in either strenuous sports activities or daily living.
1 secondary outcome
Radiological outcome
Time frame: Assessment of both groups was performed using weight-bearing standing radiographs to evaluate the degree of varus correction and screen for potential complications at 2-weeks (group1), 6-weeks, 3-months and 6-months postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background1. Dean, C.S., et al., Clinical outcomes of high tibial osteotomy for knee instability: a systematic review. Orthopaedic journal of sports medicine, 2016. 4(3): p. 2325967116633419. 2. Gkekas, N.K., et al., Medial open wedge high tibial osteotomy is a viable option in young patients with advanced arthritis in a long-term follow-up. Knee Surgery, Sports Traumatology, Arthroscopy, 2025. 33(3): p. 1025-1032. 3. Kim, K.J., et al., Biomechanical study of the fixation plates for opening wedge high tibial osteotomy. Knee Surgery & Related Research, 2015. 27(3): p. 181. 4. Van Haeringen, M., et al., Opening-and closing-wedge high tibial osteotomy are comparable and early full weight bearing is safe with angular stable plate fixation: a meta-analysis. Knee Surgery, Sports Traumatology, Arthroscopy, 2023. 31(7): p. 3015-3026. 5. Lansdaal, J.R., et al., Early weight bearing versus delayed weight bearing in medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surgery, Sports Traumatology, Arthroscopy, 2017. 25(12): p. 3670-3678. 6. Jiang, Y., et al., Clinical and radiographic outcomes of double-triangle locking compression plate (DT-LCP) versus T-shaped locking compression plate (T-LCP) in medial open-wedge high tibial osteotomy: a follow-up study of over 5 years. Journal of Orthopaedic Surgery and Research, 2026. 21(1): p. 1. 7. Saad, R., et al., Six Weeks in Orthopedics: Biological Basis, Clinical Practice, and Evidence for a Universal Benchmark. Orthopedic Reviews, 2026. 18: p. 156461. 8. Elsenosy, A.M., et al., Early Versus Delayed Weight-Bearing Following Tibial Plateau Fracture Surgery: A Systematic Review and Meta-Analysis. Cureus, 2025. 17(10). 9. Higgins, L.D., et al., Reliability and validity of the International Knee Documentation Committee (IKDC) subjective knee form. Joint Bone Spine, 2007. 74(6): p. 594-599. 10. Collins, N., et al., Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis and cartilage, 2016. 24(8): p. 1317-1329. 11. Resch, T., et al., Open-wedge high tibial osteotomy with and without bone void filler: Allograft leads to faster bone union and weight bearing with comparable return to work and sports rates. Knee Surgery, Sports Traumatology, Arthroscopy, 2024. 32(7): p. 1785-1797. 12. Rocca, M.S., K. Dias, and J.D. Hughes, Joint preservation procedures: osteotomies about the knee. Annals of joint, 2025. 10: p. 17. 13. Azuma, T., et al., In-hospital grouping rehabilitation of hybrid closed-wedge high tibial osteotomy results in shorter hospital stays and better clinical outcomes. Journal of Physical Therapy Science, 2023. 35(8): p. 575-580. 14. Ueda, Y., et al., Knee extensor strength normalised to body weight is associated with patient-reported outcomes at 12 months after open-wedge high tibial osteotomy. Journal of Experimental Orthopaedics, 2026. 13(1): p. e70625. 15. Nha, K.-W., et al., Fixation stability and stress redistribution following metal block use in opening-wedge high tibial osteotomy: a finite element analysis. Frontiers in Bioengineering and Biotechnology, 2025. 13: p. 1703140. 16. Franulic, N., et al., Lateral hinge fracture in medial opening wedge high tibial osteotomy: a narrative review. EFORT Open Reviews, 2023. 8(7): p. 572-580.
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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.
Hatem Galal Said, Professor study chair
Professor of orthopaedic and trauma surgery, Assiut University
Mohamed Abdel Radi, Professor study director
Professor of orthopaedic and trauma surgery, Assiut University
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 post operative and Non weight bearing Post-operative in people with Knee Osteoarthritis, run by Assiut 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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical outcome (time frame: All patients of both groups underwent a clinical evaluation at 6-weeks, 3-months and 6-months post-operatively to assess knee range of motion and return to daily activity life.). 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 NCT07583264, 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 13 May 2026.