Management of Combined Patellofemoral and Medial Compartment Knee Osteoarthritis

Официальное название

Evaluation of the Results of High Tibial Osteotomy with or Without Lateral Patellar Facetectomy in Treatment of Combined Patellofemoral and Medial Compartment Knee Osteoarthritis; a Comparative Study

Обзор

Evaluate the results of management of patients with patellofemoral and medial compartment knee osteoarthritis with open wedge high tibial osteotomy with or without arthroscopic partial lateral patellar facetectomy

Подробное описание

Patients will undergo OWHTO in a standardized fashion by the same team of surgeons.

They will be randomly divided into 2 groups either OWHTO with arthroscopic partial lateral patellar facetectomy or OWHTO without arthroscopic partial lateral patellar facetectomy in a 1:1 ratio.

The patient will be placed supine on the operating table. After the induction of spinal anesthesia, a knee examination will be performed to evaluate for any concurrent pathology and to assess for knee range of motion, patellar mobility, position, instability, and patellar crepitus during knee flexion. A well-padded thigh tourniquet will be placed on the upper thigh of the operative leg to maintain a bloodless field. The surgical leg will be prepared and draped in a sterile fashion, the leg exsanguinated, and the tourniquet inflated. an arthroscope will be inserted through the anteromedial, anterolateral and suprapatellar portals to access the entire perimeter of the patella. The joint will be insufflated with normal saline and visualized with a 30 degree arthroscope. Diagnostic arthroscopy will be performed in all cases to assess PF articular cartilage degeneration, classify the cartilage defect using the Outterbridge classification , assess the lateral compartment and exclude any other pathology. An arthroscopic shaver will be inserted into the knee and any notable adhesions will be removed. Any meniscal, cartilage, or ligamentous injury may be treated first. The knee will be taken throughout a range of motion to directly visualize the impingement of the lateral patellar facet against the trochlea. Next, a radiofrequency probe will be used to outline the area to be resected along the lateral patellar facet While maintaining the knee at 20 degree of flexion, a 5.5-mm burr is introduced, and under arthroscopic visualization, the lateral patellar osteophyte and the overhanging portion of the lateral facet will be carefully resected. Once the bony resection is complete, the knee is dynamically re-evaluated (through flexion and extension) for residual impingement and to assess for improvements in patellar mobility. Patellar tracking will be assessed to verify that there is no catching in flexion and that patellar mobility is improved.

After arthroscopic partial lateral patellar facetectomy, all patients will undergo OWHTO. All procedures will be performed based on the technique recommended by the AO international knee expert group. Biplanar osteotomy, which comprises osteotomies in the axial and frontal planes, was performed in all cases. Ascending frontal osteotomy, leaving the tibial tuberosity on the distal fragment, was also performed. All osteotomies will be performed without the use of additional bone grafts, and the opening of the osteotomy will be maintained with a Tomofix plate (Orthomed-E Co., Egypt). Wound closure was performed in layers.

Вмешательства

• Процедура open wedge high tibial osteotomy
  All procedures will be performed based on the technique recommended by the AO international knee expert group. Biplanar osteotomy, which comprises osteotomies in the axial and frontal planes, will be performed in all cases. Ascending frontal osteotomy, leaving the tibial tuberosity on the distal fragment, will be also performed. All osteotomies will be performed without the use of additional bone grafts, and the opening of the osteotomy was maintained with a Tomofix plate (Orthomed-E Co., Egypt)
• Процедура Arthroscopic partial lateral patellar facetectomy
  Diagnostic arthroscopy will be performed in all cases to assess Patellofemoral articular cartilage degeneration , assess the lateral compartment and exclude any other pathology. The knee is taken throughout a range of motion to directly visualize the impingement of the lateral patellar facet against the trochlea. Next, a radiofrequency probe is used to outline the area to be resected along the lateral patellar facet While maintaining the knee at 20 degrees of flexion, a 5.5-mm burr is introduced

Первичные конечные точки

• Knee injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: during the follow-up period for 2years (2 weeks, 4 weeks, 6 weeks, 6 months, 1 year, and 2 years postoperatively)]
• Kujala Score (Anterior Knee Pain Scale - AKPS) [Срок оценки: during the follow-up period for 2 years (2 weeks, 4 weeks, 6 weeks, 6 months, 1 year, and 2 years postoperatively)]

Критерии участия

Критерии включения

• Age 35-60years
• Mild to moderate TFOA (G I-II-III) Kellgren-Lawrence (KL) scale (16)
• Anterior knee pain (PFOA)
• No involvement of the lateral compartment
• range of motion of at least 120° flexion
• Body mass index (BMI) <30kg/m2
• varus angle degree <10°

Критерии исключения

• advanced case of TFOA (G VI KL scale), which requires total knee replacement.
• flexion deformity ≥15°
• inflammatory disease (such as rheumatoid arthritis).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of medicine, Sohag university — Sohag

Публикации

• Otsuki S, Murakami T, Okamoto Y, Nakagawa K, Okuno N, Wakama H, Neo M. Risk of patella baja after opening-wedge high tibial osteotomy. J Orthop Surg (Hong Kong). 2018 May-Aug;26(3):2309499018802484. doi: 10.1177/2309499018802484. PMID 30295136
• El-Azab H, Glabgly P, Paul J, Imhoff AB, Hinterwimmer S. Patellar height and posterior tibial slope after open- and closed-wedge high tibial osteotomy: a radiological study on 100 patients. Am J Sports Med. 2010 Feb;38(2):323-9. doi: 10.1177/0363546509348050. Epub 2009 Dec 31. PMID 20044496
• Loia MC, Vanni S, Rosso F, Bonasia DE, Bruzzone M, Dettoni F, Rossi R. High tibial osteotomy in varus knees: indications and limits. Joints. 2016 Aug 18;4(2):98-110. doi: 10.11138/jts/2016.4.2.098. eCollection 2016 Apr-Jun. PMID 27602350
• Iijima H, Fukutani N, Isho T, Yamamoto Y, Hiraoka M, Miyanobu K, Jinnouchi M, Kaneda E, Aoyama T, Kuroki H, Matsuda S. Changes in clinical symptoms and functional disability in patients with coexisting patellofemoral and tibiofemoral osteoarthritis: a 1-year prospective cohort study. BMC Musculoskelet Disord. 2017 Mar 24;18(1):126. doi: 10.1186/s12891-017-1486-4. PMID 28340623
• Iijima H, Fukutani N, Aoyama T, Fukumoto T, Uritani D, Kaneda E, Ota K, Kuroki H, Matsuda S. Clinical Impact of Coexisting Patellofemoral Osteoarthritis in Japanese Patients With Medial Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2016 Apr;68(4):493-501. doi: 10.1002/acr.22691. PMID 26315986
• Kim YM, Joo YB. Patellofemoral osteoarthritis. Knee Surg Relat Res. 2012 Dec;24(4):193-200. doi: 10.5792/ksrr.2012.24.4.193. Epub 2012 Nov 29. PMID 23269956
• Kobayashi S, Pappas E, Fransen M, Refshauge K, Simic M. The prevalence of patellofemoral osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2016 Oct;24(10):1697-1707. doi: 10.1016/j.joca.2016.05.011. Epub 2016 May 14. PMID 27188684
• Iwano T, Kurosawa H, Tokuyama H, Hoshikawa Y. Roentgenographic and clinical findings of patellofemoral osteoarthrosis. With special reference to its relationship to femorotibial osteoarthrosis and etiologic factors. Clin Orthop Relat Res. 1990 Mar;(252):190-7. PMID 2302884

Идентификаторы

NCT: NCT06762171 · Soh-Med-24-12---2MD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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