Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, Aurangabad, Maharashtra, India.
Department of Orthopedics, MGM Medical College and Hospital, Aurangabad, Maharashtra, India.
Arch Orthop Trauma Surg. 2024 Jun;144(6):2481-2489. doi: 10.1007/s00402-024-05347-w. Epub 2024 May 2.
Patients are often instructed to avoid weight bearing on the proximal tibia for 6 - 12 weeks post-surgery to avoid fracture fixation failure. However, delayed weight bearing leads to delayed mobility, causing difficulties in daily activities; problems such as pain, limited knee ROM, reduced quadriceps muscle strength, and impaired functional outcomes are reported in long-term follow-up. This study primarily aimed to evaluate the feasibility and explore the effect size. The secondary aim was to determine the effectiveness of early weight bearing along with conventional physiotherapy on functional outcomes.
A single-blinded pilot randomized controlled trial with 30 participants with proximal tibia type I, II, and III fractures were included; they were randomized using computer-based software. Seven patients were lost to follow-up. Group I received early weight bearing along with conventional physiotherapy whereas Group II received restricted weight bearing along with conventional physiotherapy. Assessments were made on post-operative day 3 (POD-03), at discharge, at 6 weeks, and at 12 weeks. Radiographs were recorded immediately after the operation, at discharge, and at 12 weeks.
A full-scale RCT is feasible with an effect size between 0.3 - 0.7. A statistically significant difference (p < 0.05) was found within both groups 12 weeks post-surgery in all outcome measures; the difference was more prominent in the intervention group. A statistically significant difference (p < 0.05) was found between both the groups post-12 weeks in all outcome measures except quadriceps isometric muscle strength.
A full-scale RCT for early weight bearing along with conventional physiotherapy for patients operated for Type I, II, and III proximal tibia fracture is feasible. Early weight bearing along with conventional physiotherapy could have a positive effect on reducing patient's pain perception and increasing knee joint mobility, quadriceps isometric muscle strength, knee function, and quality of life without any adverse effects.
ClinicalTrialsRegistry.gov (CTRI/2022/10/046797).
患者术后通常被指示避免负重于胫骨近端 6-12 周，以避免骨折固定失败。然而，延迟负重会导致活动延迟，从而导致日常活动困难；长期随访中报告了疼痛、膝关节活动度受限、股四头肌力量减弱以及功能结果受损等问题。本研究主要旨在评估可行性并探索效果大小。次要目的是确定早期负重结合常规物理治疗对功能结果的有效性。
一项单盲试点随机对照试验纳入了 30 名胫骨近端 I、II 和 III 型骨折患者；他们使用基于计算机的软件进行随机分组。7 名患者失访。第 I 组接受早期负重结合常规物理治疗，第 II 组接受限制负重结合常规物理治疗。在术后第 3 天（POD-03）、出院时、6 周和 12 周进行评估。在手术后立即、出院时和 12 周拍摄 X 光片。
全规模 RCT 是可行的，效果大小在 0.3-0.7 之间。两组在术后 12 周的所有结局测量中均发现有统计学显著差异（p<0.05）；干预组的差异更为显著。两组在除股四头肌等长肌肉力量外的所有结局测量中在 12 周后均发现有统计学显著差异（p<0.05）。
胫骨近端 I、II 和 III 型骨折患者术后早期负重结合常规物理治疗的全规模 RCT 是可行的。早期负重结合常规物理治疗可能对减轻患者的疼痛感知、增加膝关节活动度、股四头肌等长肌肉力量、膝关节功能和生活质量产生积极影响，而无任何不良影响。
ClinicalTrialsRegistry.gov（CTRI/2022/10/046797）。
