Clinical and Radiographic Outcomes of Medial Open-wedge High Tibial Osteotomy

Osteo Arthritis Knee Clinical Trial

Official title:

Effect of Medial Open Wedge High Tibial Osteotomy on Clinical and Radiographic Outcomes of Patients With Knee Osteoarthritis : A Retrospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04036266
• Other study ID #: MOWHTO in OA
• Status: Not yet recruiting
• Start date: October 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Mohamed S. Abdelhamid, MBBCh
• Phone: +201033589233
• Email: mohamedsalah.medic[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 .

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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Age less than 30 years old.

• Patients who had HTO for another reasons other than knee OA.

• Combined injury to (collateral ligaments, cruciate ligament).

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• medial open wedge high tibial osteotomy
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 )

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Altay MA, Ertürk 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. — View Citation

Heidari B. Knee osteoarthritis diagnosis, treatment and associated factors of progression: part II. Caspian J Intern Med. 2011 Summer;2(3):249-55. Review. — View Citation

Kim 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. — View Citation

Mukherjee 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. — View Citation

Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012 Jan 1;85(1):49-56. Review. Erratum in: Am Fam Physician. 2012 Nov 15;86(10):893. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief is being assessed using Visual analogue scale (VAS)	assessment is done using Visual analogue scale (VAS)	1 year up to 5 years post operative
Secondary	varus malalignment correction of the knee	this is measured using femoral tibial angle	1 year up to 5 years post operative