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临床试验/NCT05113901
NCT05113901终止4 期

Methylprednisolone Taper to Treat Delayed Post-Operative Recovery After Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年3月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
4
试验地点
1
主要终点
Range of Motion in Degrees at Pre and Post Treatment

研究概览

简要总结

To evaluate the efficacy of a methylprednisolone taper on patients with decreased range of motion (ROM) or delayed recovery in the acute postoperative period following total knee arthroplasty (TKA).

Patients with decreased ROM or delayed recovery six weeks to three months post-TKA will improve ROM and patient-reported outcomes at two weeks post-treatment initiation of methylprednisolone taper, as compared to similar patients who receive a placebo taper.

详细描述

Total knee arthroplasty (TKA) is one of the most performed and efficacious orthopaedic procedures, with an estimated 7 million people living with a total knee prosthesis in 2010.1 The number of annual TKAs is predicted to increase by 85% by 2030 and 143% by 2050, equating to 1.26 million2 and 1.5 million3 procedures per year, respectively. In recent studies, knee prostheses have demonstrated their efficacy in 10-, 20-, and 25-year survival rates of 96.1%, 89.7%4, and 82.3%5, respectively. Similarly, comparing functional and patient-reported outcomes before and after surgery have confirmed the high success rate achieved with this procedure.6-10 However, recovery following total knee arthroplasty (TKA) in the acute postoperative period is variable. Most clinical improvements are achieved within the first three months postoperatively but can continue up to one year.11 There is currently a paucity of data evaluating the efficacy of oral corticosteroids in the six-week to three-month postoperative period in slowly recovering patients.

Few treatments have been studied for patients who fail to achieve early range of motion or pain reduction milestones in the perioperative period. Periarticular and systemic corticosteroids improve pain and function in the immediate postoperative period, without an increase in adverse events.12-16 Additional doses of corticosteroids administered at 24 and 48 hours postoperatively have demonstrated greater improvements in pain and ROM compared to perioperative administration, with no difference in complication rates.17-20 However, few studies have evaluated the use of oral corticosteroids within a multimodal pain management regimen. Gardiner et al. evaluated low-dose steroids 10 days immediately following lumbar laminectomy and/or discectomy, in addition to a standard opioid regimen, and reported decreased subjective pain scores.21 Gottshalk et al. reported decreased patient reported pain from postoperative days 4-7 in early published results of a randomized controlled trial investigating administration of a methylprednisolone taper immediately following distal radius repair.22 Importantly, the current literature demonstrates low- and short-dose corticosteroids are safe.23 Intraoperative corticosteroids have been shown to improve pain and function in the acute postoperative period, and additional doses in the immediate postoperative period can potentiate and prolong this beneficiary effect, without increasing adverse events. Therefore, a methylprednisolone taper six weeks post-TKA may benefit patients experiencing decreased ROM or delayed recovery, including residual pain.

Following TKA, care is taken to control pain, swelling, and stiffness, all of which may contribute to delayed recovery. For instance, more than 20% of TKA patients develop postoperative stiffness,24 known as arthrofibrosis, accounting for an estimated 28% of 90-day hospital readmissions.25 In treating patients with delayed recovery, corticosteroids are of particular interest because of its potent anti-inflammatory effect, evidenced by its ability to decrease postoperative levels of IL-6 and CRP.15 Corticosteroids block prostaglandin synthesis, which is responsible for sensitizing nociceptive pain receptors, and reduce vascular permeability, which causes edema following surgery.26, 27 Therefore, by reducing pain and edema, corticosteroids may allow for more effective physical therapy sessions and more rapid improvement in ROM and recovery following TKA.

To the best of our knowledge, this is the first study to investigate the utility of a methylprednisolone taper six weeks to three months postoperatively following TKA. The authors present a double-blinded, randomized-controlled trial evaluating the role of a methylprednisolone taper on patients with decreased ROM or delayed recovery in the acute postoperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Any patient undergoing primary TKA with a diagnosis of osteoarthritis
  • ≥ 18 years old
  • ROM <90° by 3 weeks postoperatively without improvement to >90° by 6 weeks
  • Requiring a 30-pill oxycodone refill
  • NSAID allergy
  • Thigh circumference discrepancy >2cm between legs from 3 to 6 weeks
  • Defense and Veterans Pain Rating Scale (DVPRS) > 5 between 3 and 6 weeks
  • Willingness to undergo randomization

排除标准

  • Reported chronic corticosteroid or opiate use
  • Suspected or confirmed periprosthetic joint infection
  • Revision TKA
  • Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis
  • American Society of Anesthesiologists (ASA) score ≥ 4
  • Reported history of liver or renal disease
  • Uncontrolled diabetes
  • Immunosuppression
  • ≤ 18 years old
  • Inability to take oral medications
  • Unable to provide consent

研究组 & 干预措施

Placebo taper

Placebo Comparator

21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM <90° at 8 weeks

干预措施: Placebo (Drug)

Methylprednisolone taper

Active Comparator

21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM <90° at 8 weeks

干预措施: Methylprednisolone (Drug)

结局指标

主要结局

Range of Motion in Degrees at Pre and Post Treatment

时间窗: Baseline, Week 6 Following Treatment

Range of motion (ROM) from pre-treatment to six weeks following treatment. Patients started treatment after total knee replacement surgery and presented to clinic with at least one inclusion criteria to be enrolled. Range of motion in degrees is taken at each visit by a clinician (standard of care), starting at zero degrees (straight leg) to about 135 degrees. The ROM was documented as part of consenting and enrollment into study. Subjects returned to the office at 6 weeks post treatment where ROM was performed in a clinic setting once again and documented. ROM is done using a goniometer by a clinician in each clinic. This study was terminated early, therefore of the 4 enrolled, zero were randomized to the placebo group. Only 1 of the four subjects completed the 6 weeks, however, ROM was captured on all as standard of care.

次要结局

  • Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores(pre treatment)
  • Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores(Days 1 through 6 following treatment)
  • Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment(6 weeks after treatment)
  • Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)(6 weeks post treatment)
  • Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment(6 weeks after treatment)
  • Number of Participants With Complications Following Treatment(within 90 days after initial total knee arthroplasty)
  • Patient Reported Outcome Measures: Post Treatment Pain Scores(6 weeks post treatment)
  • Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment(pre treatment)
  • Adverse Events or Outcomes Outside of Manipulations Under Anesthesia(within 90 days after initial total knee arthroplasty)
  • Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment(pre treatment)
  • Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment(6 weeks after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vasili Karas

Assistant Professor, Orthopedic Surgery

Rush University Medical Center

研究点 (1)

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