A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery

Официальное название

Is Full Weight Bearing After the Modified Lapidus Operation Possible? A Randomized Controlled Trial to Compare Early and Partial Weight-bearing

Обзор

This is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified Lapidus arthrodesis with/without an Akin or a Weil/Hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks as a novel approach for rehabilitation after a foot surgery.

Подробное описание

The surgical operation will be carried out according to the standard clinical practice, namely following the modified Lapidus general and specific rules concerning the surgical treatment of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients who meet the eligibility criteria will be randomized into one of the two groups (partial weight-bearing limited at 15kg vs full weight-bearing) Patient in both groups will be wearing a VACOPASO shoe for 6 weeks.

Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at weeks 6, 12, 24.

Change in pain severity from the day of surgery to 6, 12 and 24 weeks postoperatively will be measured using the pain Visual Analogue Scale (VAS). Quality of life will be assessed through the American Orthopedic Foot and Ankle Score (AOFAS). Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).

Вмешательства

• Другое Partial weight-bearing (10 - 15kg)
  Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks
• Другое Complete weight-bearing
  Complete post-operative weight-bearing with a VACOPASO shoe for 6 weeks

Первичные конечные точки

• Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS) [Срок оценки: at 6 weeks]

Вторичные конечные точки (4)

• Pain on a Visual Analogue Scale [Срок оценки: At the day of surgery, at 6, 12 and 24 weeks postoperatively.]
• Bone consolidation through anteroposterior and lateral foot x-rays [Срок оценки: 6 weeks and 12 weeks. At 24 weeks in case of fracture non-union reported at the 12th week postoperatively]
• American Orthopedic Foot and Ankle Score questionnaire [Срок оценки: at 6, 12 and 24 weeks]
• Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS) [Срок оценки: at 12 and 24 weeks]

Критерии участия

Критерии включения

• Patient who undergo modified Lapidus arthrodesis operation and associated with:
• Additional surgical gestures such as e.g. interventions on the proximal phalanx of the first finger (Akin) or interventions on the 2nd and / or 3rd ray (Weil / Hohmann) \[23,24\].
• Willingness and ability to participate in the trial
• Signed Informed Consent

Критерии исключения

• Diabetes mellitus
• Rheumatoid arthritis
• Previous foot surgery
• Classic Lapidus surgery
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
• Inability or contraindications to undergo the investigated intervention
• Pregnant women

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

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• EOC — Lugano

Публикации

• Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553. PMID 6437370
• LAPIDUS PW. A quarter of a century of experience with the operative correction of the metatarsus varus primus in hallux valgus. Bull Hosp Joint Dis. 1956 Oct;17(2):404-21. No abstract available. PMID 13413410
• Butson AR. A modification of the Lapidus operation for hallux valgus. J Bone Joint Surg Br. 1980 Aug;62(3):350-2. doi: 10.1302/0301-620X.62B3.6997319. PMID 6997319
• Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701. PMID 7951968
• Drummond D, Motley T, Kosmopoulos V, Ernst J. Stability of Locking Plate and Compression Screws for Lapidus Arthrodesis: A Biomechanical Comparison of Plate Position. J Foot Ankle Surg. 2018 May-Jun;57(3):466-470. doi: 10.1053/j.jfas.2017.10.025. Epub 2018 Feb 19. PMID 29472168
• Ray RG, Ching RP, Christensen JC, Hansen ST Jr. Biomechanical analysis of the first metatarsocuneiform arthrodesis. J Foot Ankle Surg. 1998 Sep-Oct;37(5):376-85. doi: 10.1016/s1067-2516(98)80045-8. PMID 9798168
• Sangeorzan BJ, Hansen ST Jr. Modified Lapidus procedure for hallux valgus. Foot Ankle. 1989 Jun;9(6):262-6. doi: 10.1177/107110078900900602. PMID 2744666
• Myerson M, Allon S, McGarvey W. Metatarsocuneiform arthrodesis for management of hallux valgus and metatarsus primus varus. Foot Ankle. 1992 Mar-Apr;13(3):107-15. doi: 10.1177/107110079201300301. PMID 1601337

Идентификаторы

NCT: NCT05534724 · ORL-ORT-033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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