Early Weight Bearing After Open Wedge High Tibial Osteotomy (OWHTO), Is it Worth?

NCT07583264 | Active Not Recruiting

• 1 other identifier: High tibial Osteotomy in Knee
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

deformity correction; High tibial Osteotomy; Knee Arthroscopy; Knee Synovitis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

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.

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

Other: Non weight bearing Post-operative

Interventions

Early weight bearing post operative OTHER

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.

Early weight bearing group

Non weight bearing Post-operative OTHER

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.

Non weight bearing group

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.
• Revision HTO.
• Meniscal root repair.
• Lateral meniscal injury.
• Mal-united Fr. Tibial plateau.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71111, Egypt

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hatem Galal Said, Professor

  Professor of orthopaedic and trauma surgery, Assiut University

  STUDY CHAIR

• Mohamed Abdel Radi, Professor

  Professor of orthopaedic and trauma surgery, Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Orthopaedic and traumatology, Assiut University Hospital

Model Details: parallel-groups superiority randomized controlled blinded trial

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start: March 8, 2024
• Primary Completion: March 8, 2025
• Study Completion (Estimated): June 8, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

EG (1)