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临床试验/NCT07223359
NCT07223359已完成不适用

The Impact of Photographic Evidence on Postoperative Range of Motion Following Total Knee Arthroplasty: A Randomized Control Trial

Loyola University4 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
4
主要终点
Knee Flexion at Six Weeks Postoperatively

研究概览

简要总结

Historically, total knee arthroplasty (TKA) has been performed to restore knee range of motion and relieve pain, with postoperative rehabilitation focused on helping patients regain mobility and function. This study evaluates whether providing patients with photographic evidence of their knee range of motion immediately after surgery can enhance short-term recovery.

Patients will be randomly assigned to one of two groups: one group will receive printed photographs showing their knee in full flexion immediately after surgery, while the other group will not receive photographs. Outcomes assessed at six weeks postoperatively will include knee range of motion, physical therapy progress metrics, length of hospital stay, and patient-reported outcomes.

详细描述

Participants include patients 18 years or older presenting to the investigators' institutions who are scheduled to undergo a primary total knee arthroplasty (TKA). Exclusion criteria include revision TKA, prior surgery or fracture involving the operative knee, preoperative knee flexion contracture greater than 10 degrees, patients with comorbidities, and those unable or unwilling to provide informed consent.

If, after evaluation, the patient remains eligible, the surgeon will introduce the study. If the patient expresses interest, a member of the study team will approach the patient to explain the study in detail. The voluntary nature of participation will be emphasized, and the prospective participant will be encouraged to ask questions and discuss participation with others. Once all questions have been addressed, the participant will be presented with the informed consent document (ICD). The study team member will step out of the room to allow time for review. If desired, the participant may take a paper copy of the ICD to discuss with family or others before signing. Once all questions have been answered to the participant's satisfaction, the ICD will be signed, preferably in the clinic. If the participant elects to take the ICD home, a follow-up time will be arranged, typically during preoperative clearance or on the day of surgery to review and sign the document.

After informed consent is obtained, preoperative baseline data including range of motion and patient-reported outcome measures will be collected. Participants will then be randomized in a 1:1 fashion to either receive or not receive photographic evidence of their postoperative knee range of motion. Randomization will be performed using stratified randomization lists generated and maintained by the Biostatistics Core at Loyola University Clinical Research Office to ensure equal allocation across sites.

During surgery, photographs of the operated knee in full flexion and full extension will be taken. Participants randomized to the intervention group will receive printed copies of the photographs and instructions to share them with their physical therapist. The control group will not receive any photographs. All participants will receive standard perioperative management, surgical technique, and rehabilitation protocols.

The primary outcome is knee flexion at six weeks postoperatively, measured using a goniometer by a blinded assessor. Secondary outcomes include knee extension, physical therapy progress metrics (total duration of therapy, time to achieve 110 degrees of flexion, and number of therapy sessions), distance walked on postoperative day one, length of hospital stay, and patient-reported outcomes via the Knee Injury and Osteoarthritis Outcome Score (KOOS) survey.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (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

  • Adults aged 18 years or older
  • Scheduled to undergo primary unilateral total knee arthroplasty (TKA) at one of the investigators' participating institutions
  • Able to understand study procedures and comply with follow-up requirements
  • Able to read and complete questionnaires in English
  • Willing and able to provide informed consent prior to participation

排除标准

  • Undergoing revision TKA
  • History of prior surgery or fracture involving the operative knee
  • Preoperative knee flexion contracture >10 degrees
  • Patients with non-elective or trauma-related indications for knee replacement
  • Inability or unwillingness to provide informed consent

结局指标

主要结局

Knee Flexion at Six Weeks Postoperatively

时间窗: 6 weeks after total knee arthroplasty

Knee flexion will be measured in degrees using a goniometer by a blinded assessor at the 6-week postoperative visit. The outcome compares the degree of maximum flexion between participants who received photographic evidence of their postoperative range of motion and those who did not.

次要结局

  • Knee Extension at Six Weeks Postoperatively(6 weeks after total knee arthroplasty)
  • Total Duration of Physical Therapy(Up to 6 weeks after surgery)
  • Length of Hospital Stay(From the date of surgery until the date of hospital discharge, assessed for up to 6 weeks postoperatively.)
  • Total Number of Physical Therapy Sessions(Up to 6 weeks after surgery)
  • Time to Achieve 110° of Knee Flexion (Weeks)(Up to 6 weeks after surgery)
  • Time to Achieve 110° of Knee Flexion (Sessions)(Up to 6 weeks after surgery)
  • Distance Walked on Postoperative Day One(Postoperative day 1)
  • Patient-Reported Outcome Measures (KOOS Survey)(6 weeks after surgery)

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Brown

Principal Investigator

Loyola University

研究点 (4)

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