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

NCT04036266 | Unknown

• 1 other identifier: MOWHTO in OA
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• varus malalignment correction of the knee

  1 year up to 5 years post operative

Interventions

medial open wedge high tibial osteotomy PROCEDURE

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 )

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients older than 30 years old that underwent medial open wedge high tibial osteotomy due to medial osteoarthritis of the knee

You may qualify if:

• 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.

You may not qualify if:

• Age less than 30 years old.
• Patients who had HTO for another reasons other than knee OA.
• Combined injury to (collateral ligaments, cruciate ligament).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

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

  PMID: 24049581 BACKGROUND

• 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.

  PMID: 30080423 BACKGROUND

• 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.

  PMID: 25154146 BACKGROUND

• Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012 Jan 1;85(1):49-56.

  PMID: 22230308 BACKGROUND

• Altay MA, Erturk 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.

  PMID: 26194919 BACKGROUND

Study Officials

• Mohamed M. Abdelhamid, PHD

  Professor of Orthopedics and Traumatology

  STUDY CHAIR

• Islam K. Ramadan, PHD

  Lecturer of Orthopedics and Traumatology

  STUDY DIRECTOR

Central Study Contacts

Mohamed S. Abdelhamid, MBBCh

CONTACT

+201033589233; mohamedsalah.medic@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in orthopedic and traumatology department

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: July 29, 2019
• Study Start: October 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 1, 2020
• Last Updated: September 17, 2019

Record last verified: 2019-09