Early Weight Bearing After Open Wedge High Tibial Osteotomy (OWHTO), Is it Worth?
8 maj 2026 uppdaterad av: Mohamed Abdel-Tawab, Assiut University
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.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
72
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypten, 71111
- Assiut University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- 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 .
Exclusion Criteria:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Early weight bearing group
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.
|
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.
|
|
Aktiv komparator: Non weight bearing group
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
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical outcome
Tidsram: 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.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Radiological outcome
Tidsram: 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.
|
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. |
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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Hatem Galal Said, Professor, Professor of orthopaedic and trauma surgery, Assiut University
- Studierektor: Mohamed Abdel Radi, Professor, Professor of orthopaedic and trauma surgery, Assiut University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 mars 2024
Primärt slutförande (Faktisk)
8 mars 2025
Avslutad studie (Beräknad)
8 juni 2026
Studieregistreringsdatum
Först inskickad
28 april 2026
Först inskickad som uppfyllde QC-kriterierna
8 maj 2026
Första postat (Faktisk)
13 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- High tibial Osteotomy in Knee
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .