A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.

Официальное название

A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)

Обзор

The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery. It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.

Вмешательства

• Устройство Hip stem prosthesis
  The Insignia hip stem prosthesis will be used in cementless total hip replacement surgery (THA). The surgery typically takes approximately two hours. All study participants will receive the Insignia hip stem and compatible components. Experienced Orthopaedic Surgeons trained in THA will perform the surgeries as per the standard surgical technique guide for this prosthesis.

Первичные конечные точки

• Implant survivorship [Срок оценки: 2 years post-operatively]

Вторичные конечные точки (9)

• Oxford Hip Score [Срок оценки: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
• Hip Disability and Osteoarthritis Outcome Score (HOOS-12). [Срок оценки: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
• EQ-5D-5L [Срок оценки: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
• Hip and lower back pain VAS [Срок оценки: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
• Forgotten Joint Score (FJS) [Срок оценки: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
• Complications [Срок оценки: Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively.]
• Mortality [Срок оценки: 1 and 2 years post-operatively]
• CPR for stem loosening [Срок оценки: 2 years post-operatively]
• Femoral fracture [Срок оценки: 2 years post-operatively]

Критерии участия

Критерии включения

• The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Patient Information Consent Form for the use of the study device
• Primary non-inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis) and/or rheumatoid arthritis
• The patient is a candidate for a primary cementless THA.
• Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.

Критерии исключения

• Active or suspected latent infection in or about the affected hip joint and the time of study device implantation.
• Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in post-operative care.
• Has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
• Is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. >30 days.)
• Requires revision THA or hip fusion to the affected joint.
• Has known sensitivity to device materials.
• Any involvement in an active Workers' Compensation investigation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• St John of God Subiaco Hospital — Subiaco

Идентификаторы

NCT: NCT06108934 · Insignia-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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