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临床试验/NCT05502679
NCT05502679已完成不适用

Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation: A Randomized Clinical Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
The change in Oxford knee score (OKS) from 6 weeks to 3 months and 6 months after surgery

研究概览

简要总结

Postoperative rehabilitation for tibial plateau fracture generally involves prolonged non-weight bearing time while other protocols use partial weight-bearing and bracing before full weight-bearing is recommended at 9 to 12 weeks following surgical fixation. No study to date has investigated the effect of standardized pragmatic exercise protocol added to immediate weight bearing after tibial plateau fractures surgical fixation on patient's functional outcomes, knee ROM, pain, radiographic boney alignment, gait, and return to work.

详细描述

Tibial plateau fractures can permanently affect patients' quality of life, including significant socio-economic impact due to time off work, compromised knee functional integrity, secondary knee osteoarthritis, knee flexion contractures, job loss due to functional limitations, and limited ability to return to pre-injury level of sports participation. Additionally, patients with tibial plateau fracture are at greater risk of death compared to an age- and the gender-matched reference population.

In orthopedics, weight-bearing refers to how much weight a person bears through an injured body part. During a single-leg stance, a person with no physical limitations will carry 100% of their body weight through each leg. Thus, grades of weight bearing are generally expressed as a percent of the body weight. Weight-bearing grades include (1) Non-weight bearing (NWB), which means the patient is not to put any weight through the affected limb(s); (2) Toe touch weight bearing (TTWB), which is poorly defined in the literature. In clinical practice, it is commonly described as having the ability to touch the toes to the floor without supporting weight from the affected limb. The pressure should be light enough to avoid crushing a potato crisp underfoot. Partial weight bearing (PWB) can range from anything greater than non-weight bearing to anything less than full weight bearing. The status is usually accompanied by a percentage figure to describe the extent of recommended weight bearing further. Most of the definitions in the literature define partial weight bearing as being 30% to 50% of a patient's body weight. Full weight bearing (FWB) means no restriction to weight bearing. In other words, 100% of a person's body weight can be transmitted through the designated limb. This term is somewhat interchangeable with the term 'weight bear as tolerated (WBAT), which allows them to self-limit their weight bearing up to full body weight. Restriction in weight bearing of the operated leg during standing and walking is needed to avoid complications during the postoperative recovery such as mal-union, fracture reduction loss, or hardware failure.

Postoperative rehabilitation for tibial plateau fracture generally involves prolonged non-weight bearing time, while other protocols use partial weight-bearing and bracing before full weight-bearing is recommended at 9 to 12 weeks following fixation. Early weight-bearing and early range of motion (ROM) for cartilage nourishment and preservation after selected lower limb surgical procedures are associated with positive postoperative outcomes, including decreased mortality and morbidity rate, functional improvements, reduced inpatient length of stay, and improved healing process. Early weight-bearing prescription, however, has to be carefully assessed, as it may result in fracture reduction loss, hardware failure, infection, malunion, or nonunion. The effectiveness of immediate partial post-operative weight-bearing in the management of lateral tibial plateau fractures resulted in favorable outcomes after immediate partial weight-bearing of 15 kg in cases of bicondylar tibial plateau fractures fixed with medial and lateral plating, and after immediate partial weight-bearing, up to 25 kg in all types of tibial plateau fractures fixed using a range of approaches.

By using locking plates for tibial plateau fracture surgical management, surgeons can safely allow immediate postoperative weight-bearing. Immediate weight bearing did not produce additional tibial plateau depression greater than 2 mm with Schatzker Type I, II, III, or Type V fractures. This could potentially reduce the rate of postoperative complications due to immobilization, such as deep venous thrombosis and joint stiffness.

Knee ROM limitations and altered gait characteristics are common complications after tibial plateau fractures. Most gait improvements occurred within the first postoperative six months. The total ROM at each lower limb joint showed positive correlations with the patients' capability to conduct normal activities of daily living.

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, Outcomes Assessor)

盲法说明

The first patient from each type of Schatzker classification 1-4 tibial plateau fractures will be randomly assigned to either WBG or TG. Then each patient will be alternatively assigned to WBG or TG as a stratification method to ensure that each group has equal distribution from each type of Schatzker classification 1-4 tibial plateau fractures. The randomization file will be generated by an investigator (TH) not involved in the data collection process, with the results stored in a spreadsheet accessible only to the investigator responsible for the subjects' group assignment (MI). This investigator will not participate in any data collection or subject treatment. Due to the nature of the study, participants will not be blinded to the group assignment and treatment they will receive. However, the investigators measuring the dependent variables will be blinded to the group assignment.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women and men (18 to 65 years of age) admitted to Assiut University Hospital - Trauma unit with the diagnosis of traumatic tibial plateau closed fracture.
  • Open or arthroscopic internal fixation for tibial plateau fracture.
  • Schatzker classification 1-4 tibial plateau fractures.
  • An Orthopedic surgeon with at least 5 years of surgery experience.
  • Precontoured and standard locking compression plates for the tibia plateau fracture internal fixation.

排除标准

  • 1-. Contralateral limb condition that prevents weight-bearing
  • Ipsilateral injuries such as tibial or femoral fractures, hip fractures, or pelvic ring injuries.
  • Patients are required to wear a locking knee brace following the surgical fixation for a concomitant ligamentous knee injury.
  • Patient treated conservatively or with external fixation.
  • Surgical fixation is delayed for more than 10 days after the injury.
  • Requirement of involved leg fixed immobilization (e.g., cast) following the surgical fixation
  • Non-ambulatory pre-tibial plateau fracture
  • Pre-injury limitation to ROM of ipsilateral knee
  • Documented psychiatric disorder (aggressive, bipolar) requiring admission in the perioperative period.
  • Cognitive or mental condition that prevents the patient from following directions.

结局指标

主要结局

The change in Oxford knee score (OKS) from 6 weeks to 3 months and 6 months after surgery

时间窗: 6 weeks, 3 and 6 months after the surgery

Arabic version of Oxford knee score.Functional knee questionnaire.The questionnaire consists of 12 questions that cover the function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.

The change in active Knee range of motion

时间窗: Baseline, 2 and 6 weeks, 3months after the surgery

Measuring Active knee flexion and extension and at 3 month tibial rotation ROM will be measured

The change of radiograph measurements on X-ray

时间窗: Baseline and 3 months after the surgery

proximal medial tibial angle to detect varus / valgus angulation .

The change on clinical impression of reduction quality on Computed tomography

时间窗: Baseline and 3 months after the surgery

measurement of fracture gap, joint step off, tibial plateau width, tibial slope and depression will be measured to report quality of reduction and bony alignment.

次要结局

  • Return to work Assessment(3- and 6-month post-surgery)
  • The change in Hip Stability Isometric Tests and knee extensor strength using (handheld dynamometer)(6 weeks and 3 months after the surgery)

研究者

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

Mariam ibrahim

Principle investigator

Assiut University

研究点 (2)

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