Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach

Официальное название

Monocentric Randomised Controlled Trial Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach

Обзор

THA comprises the replacement of the damaged bone and cartilage with prosthetic components. The proximal end of the femur is replaced with a stem and ball/head, while the acetabulum is most commonly replaced with a unipolar cup (UP) that consists of a liner inside of a metal shell. UP cups are associated with risks of dislocations, especially in elderly and female patients, as well as in patients with lumbar stiffness or operated for femoral neck fractures. In fact, one of the most common reasons for early revision of UP cups are dislocations. Dual-mobility (DM) cups were introduced in the 1970s by the French surgeon Gilles Bousquet, as an alternative to UP cups. They are made up of two articulations, a femoral head moving inside a mobile polyethylene liner, which in turn moves inside a metal shell. This design allows for a greater jump distance and range of motion (ROM) compared to UP cups, thus resulting in reduced rates of dislocation. A recent systematic review that evaluated 5 case-control studies (549 DM cups vs 649 UP cups) and 3 registry studies (5935 DM cups vs 217362 UP) found that in case-control studies, the dislocation rates were 0.2% for DM cups versus 7.1% for UP cups (p=0.009). Furthermore, in registry studies the revision rates due to dislocation were 0.2% for DM cups versus 0.5% for UP cups (p=0.050). Nonetheless, there have been some concerns associated with the use of DM cups, including intra-prosthetic dislocations (IPD), polyethylene wear, and iliopsoas impingement. Since the early 2000s, new improvements in the design of DM cups have nearly eliminated the risk of IPD, and the use of ultra-high molecular weight polyethylene (UHMWPE) has greatly reduced wear rates, even in young and active patients. Lastly, although some studies have reported iliopsoas impingement with DM cups, the impingement is usually against the optional fixations, and not against the mobile polyethylene insert. The hypothesis of the present interventional randomised controlled trial (RCT) is that THA using DM cups will not provide inferior outcomes compared to THA using UP cups, in terms of hip awareness measured using the forgotten joint score (FJS).

Вмешательства

• Процедура Primary total hip arthroplasty using dual-mobility cup
  Replacement of hip articulating surface.
• Процедура Primary total hip arthroplasty using unipolar cup
  Replacement of hip articulating surface.

Первичные конечные точки

• Forgotten Joint Score between DM cup group and UP cup group [Срок оценки: 2 years]

Вторичные конечные точки (9)

• Forgotten Joint Score between DM cup group and UP cup group [Срок оценки: 3 months and 1 year]
• To compare the patient's hip/groin pain between DM cups versus UP cups, as well as to compare the net change from baseline [Срок оценки: preoperatively, at 3 months, 1 year and 2 years]
• To compare the patient's hip function between DM cups versus UP cups [Срок оценки: preoperatively, at 3 months, 1 year and 2 years]
• To compare the patient's sports activity between DM cups versus UP cups [Срок оценки: 1 year]
• To compare the patient's sports activity between DM cups versus UP cups [Срок оценки: preoperatively, at 1 year and 2 years]
• To compare the patient's sexual activity between DM cups versus UP cups [Срок оценки: 1 year]
• To compare the patient's sexual activity between DM cups versus UP cups [Срок оценки: 1 year]
• To compare the patient's satisfaction with surgery between DM cups versus UP cups [Срок оценки: 1 year]
• To compare adverse events (that may impact the objectives of the study) between DM cups versus UP cups [Срок оценки: intraoperatively, at 3 months, 1 year and 2 years]

Критерии участия

Критерии включения

• men and women aged ≥18 years old
• set to undergo elective primary THA via direct anterior approach (DAA)
• affiliated with a social security scheme
• able to answer questionnaires and to communicate freely in French
• who have been informed and have provided free, informed, and written consent (no later than the day of inclusion and before any examination required by the study)

Критерии исключения

• with prior ipsilateral hip surgery
• with prior contralateral hip surgery
• that require acetabular cup diameters ≤50mm (because DM cups are not available from the same manufacturer for diameters ≤50mm, and UP cups require head diameters of 36mm and thus minimum cup diameters of 52mm)
• undergoing emergency or trauma surgery (e.g. femoral neck fractures)
• with any concomitant disease or disorder which, in the opinion of the surgeon, may put the patient at risk, notably of hip instability or dislocation (hip dysplasia, neuromuscular deficit, fracture sequelae…) or may influence the result of the study
• that are pregnant or breastfeeding
• under legal protection (guardianship or curatorship or deprived of liberty).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Polyclinique Jean Villar — Bruges

Публикации

• Jones HB, Hinkle AJ, Liu Y, Sambandam SN. Multivariate Analysis of Risk Factors for In-Hospital Dislocation Following Primary Total Hip Arthroplasty. J Clin Med. 2024 Jun 13;13(12):3456. doi: 10.3390/jcm13123456. PMID 38929981
• Fessy MH, Viste A, Philippot R, Belzile EL. Recent progress in dual mobility total hip arthroplasty: an irresistible French icon. Orthop Traumatol Surg Res. 2024 Oct;110(6):103993. doi: 10.1016/j.otsr.2024.103993. Epub 2024 Sep 10. No abstract available. PMID 39265929
• Jonker RC, van Beers LWAH, van der Wal BCH, Vogely HC, Parratte S, Castelein RM, Poolman RW. Can dual mobility cups prevent dislocation without increasing revision rates in primary total hip arthroplasty? A systematic review. Orthop Traumatol Surg Res. 2020 May;106(3):509-517. doi: 10.1016/j.otsr.2019.12.019. Epub 2020 Apr 8. PMID 32278733
• Varacallo MA, Luo TD, Johanson NA. Total Hip Arthroplasty Techniques. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507864/ PMID 29939641

Идентификаторы

NCT: NCT07464665 · 2025-A01817-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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