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临床试验/NCT07834034
NCT07834034尚未招募不适用

Daycase Hip and Knee Arthroplasty in Møre and Romsdal Trial

Helse Møre og Romsdal HF3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
3
主要终点
Proportion of same day discharge

研究概览

简要总结

The DART Study is a prospective, multicentre observational cohort study evaluating day-case pathways for patients undergoing primary total hip arthroplasty, total knee arthroplasty, or unicompartmental knee arthroplasty at three hospitals in Møre og Romsdal, Norway (Volda, Ålesund and SNR). All patients scheduled for these procedures will be screened for eligibility for same-day discharge using predefined clinical, functional, and logistical criteria.

The primary objective is to determine the proportion of patients who are discharged on the day of surgery. Secondary objectives are to assess recovery, pain, complications, emergency department visits, readmissions, reoperations, and mortality during the first 30 days after surgery. Patient-reported outcomes, including quality of recovery, joint-specific function, quality of life, pain, and awareness of the joint replacement, will be assessed before surgery and during follow-up for up to three months.

Clinical and patient-reported data will be collected prospectively. Outcomes for patients discharged on the day of surgery will be compared with those of patients who remain in hospital overnight or longer. The study aims to evaluate the feasibility, safety, and patient experience of implementing standardized day-case hip and knee arthroplasty pathways within routine clinical practice.

详细描述

The increasing demand for hip and knee arthroplasty has created a need for more efficient perioperative pathways without compromising patient safety, recovery, or satisfaction. Advances in surgical technique, anaesthesia, multimodal analgesia, early mobilization, and structured follow-up have made discharge on the day of surgery feasible for selected patients. However, the proportion of patients who can complete a day-case pathway in routine clinical practice, and the reasons why intended same-day discharge is not achieved, may vary between hospitals and patient populations.

The DART Study will evaluate the implementation of a standardized day-case arthroplasty pathway across three hospitals within Møre og Romsdal Hospital Trust: Sjukehuset Nordmøre og Romsdal at Hjelset, Ålesund Hospital, and Volda Hospital. The study will include patients scheduled for primary total hip arthroplasty, total knee arthroplasty, or unicompartmental knee arthroplasty. The study is investigator-initiated and embedded in ordinary clinical care.

All patients scheduled for one of the eligible procedures during the recruitment period will be screened prospectively. Screening will document whether the patient fulfils the predefined criteria for participation in the day-case pathway.

The predefined eligibility assessment will include relevant medical, functional, cognitive, and logistical factors. Factors expected to preclude participation in the day-case pathway include severe systemic disease, advanced frailty, impaired cognition or inability to comply with instructions, body mass index above 40 kg/m², age above 80 years, and travel circumstances that make rapid access to an acute hospital difficult. Final eligibility will be determined by the treating clinical team according to the study criteria and an individual clinical assessment.

Patients included in the day-case pathway will receive standardized preoperative information and preparation. The perioperative pathway is designed to support early recovery and includes evidence-based anaesthesia, multimodal opioid-sparing analgesia, early oral intake, and mobilization shortly after surgery. Regional analgesic techniques will be adapted to the type of procedure. Patients undergoing knee arthroplasty will receive a genicular nerve block and femoral triangle block as part of the pain-management pathway. Patients undergoing total hip arthroplasty will receive a pericapsular nerve group block. The use and effect of the regional block will be documented. After a pericapsular nerve group block, the ability to perform active knee extension while sitting will be assessed as an indicator of quadriceps motor function.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18-80 years old scheduled for primary TKA, UKA or THA

排除标准

  • Patient not motivated for daycase surgery, lack of adult caregiver staying with the patient for the first 24 hours post-discharge, ASA class 3 (if not approved by anesthesiologist) and 4, travel distance to acute hospital no more than 1 hour (ferry-free), dementia or other reasons for lacking compliance (e.g. substance abuse, severe psychiatric disorder etc.) BMI >40 kg/m2, patients with anticipated high level of pain due to previous experience, comorbidity (i.e. chronic pain syndrome, fibromyalgia), patients treated with opoid analgesics on a regular basis prior to surgery.

研究组 & 干预措施

Total Hip Arthroplasty

Eligable patients for daycase surgery with hip osteoarthritis, osteonecrosis or other indication for total hip arthroplasty

干预措施: Total Hip Arthroplasty (Procedure)

Total Knee Arthroplasty

Eligable patients for daycase surgery with knee osteoarthritis, osteonecrosis or other indication for total knee arthroplasty

干预措施: Total Knee Arthroplasty (Procedure)

Unicondylar Knee Arthroplasty

Eligable patients for daycase surgery with knee osteoarthritis, osteonecrosis or other indication for unicondylar knee arthroplasty

干预措施: Unicondylar knee artrhoplasty (Procedure)

结局指标

主要结局

Proportion of same day discharge

时间窗: The primary outcome measure is measured at the day of surgery. If by any chance a patient is readmitted to hospital the day after surgery, this is counted as a readmission.

The proportion of patients that are not dicharged at the day of surgery, but are admitted to the ward for som reason including complications, social factors , PONV, pain etc. It does also include the patients readmitted on the day of surgery.

次要结局

  • Claudien-Dindo classification(peroperativ, 1 day postoperative, 7 days postoperative, 30 days postoperative and 3 months postoperative)
  • Knee Injury and Osteoarthritis Outcome Score(Preoperative and 3 months postoperative)
  • The Forgotten Joint Score (FJS) Knee(Preoperative and 3 months postoperative)
  • The Forgotten Joint Score (FJS) Hip(Preoperative and 3 months postoperative)
  • Clinical Frailty Scale(Baseline)
  • Hip disability and Osteoarthritis Outcome Score (HOOS)(Preoperative and 3 months postoperative)
  • Quality of Recovery(Baseline, Postoperative day 1, 3 and 7, 1 month and 3 months)
  • Numeric rating scale for pain (NRS)(Prepoerative, before discharge after surgery, postoperative day 1-7, 1 and 3 months postoperative.)
  • Proportion of resubmission(postoperative day 1, day 7, 1 and 3 months)
  • Serious adverse events (SAE)(Up to 3 months after surgery)
  • EQ-5D(Preoperative and 3 months postoperative)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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