Fixation Stability and Progress of Bony Healing Following Open-Wedge High- Tibial Osteotomy A 24-Subject Clinical Pilot Study Using Radio Stereometric Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The primary outcomes are the fixation stability of the implant
研究概览
简要总结
Patients undergoing opening wedge high tibial osteotomy (HTO) will be randomized to standard or locking screw fixation of the osteotomy plate. Tantalum beads will be implanted around the osteotomy site in all subjects to facilitate RSA imaging which will then allow micromotion at the osteotomy site to be quantified.
Primary Objectives and Hypothesis
- a)to determine fixation stability of the Puddu opening wedge osteotomy plate secured with non-locking compared to locking screws. We hypothesize that plate fixation with locking screws will result in a significant reduction of micromotion between tibial segments prior to bony healing compared to the non-locking screw fixation.
b)To determine the progress of bony healing. We hypothesize that increased fixation stability in patients with locking screws will facilitate early bone healing reflected by smaller micromotion over time compared to the non-locking screw patients. 2. a)If there is improved stability with the use of locking screws, rehabilitation protocols following opening wedge HTO will be modified accordingly. We hypothesize that decreasing micromotion will reach the detection limit of the RSA setup (0.4 mm) earlier in the locking screw group than in the non-locking screw group.
b)To evaluate the effect of the osteotomy on proximal tibial anatomy. We hypothesize that an open-wedge procedure might increase rather than decrease the tibial slope.
详细描述
For this pilot study, a total of 24 patients scheduled for opening wedge HTO who meet the inclusion criteria, have read the study letter of information and signed the informed consent will be randomized to osteotomy plate fixation with either non-locking screws (12 subjects) or locking screws (12 subjects). See flow chart 1.
Pre-operative Assessment
All subjects will undergo routine pre-operative assessment for opening wedge high tibial osteotomy which includes:
- Documentation of demographic data and medical history
- Subjective assessment of knee function using the Knee Injury and Osteoarthritis Outcome Score (KOOS)(11)
- Standard physical evaluation of the lower limb assessing range of motion, alignment, knee-related signs and symptoms
- Radiographs: standing anteroposterior hip-to-ankle;(2) lateral view; skyline patellar view at 30° of knee flexion; bilateral weight-bearing posteroanterior (PA) tunnel view at 45° of knee flexion
- Radiographic classification of arthrosis using the Kellgren scale(4)
- Measurements of mechanical and anatomical axes of the lower limb and calculation of proposed correction angles
Surgery In the operating room all subjects will undergo the following steps.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients between the ages of 30 and 70 years of age scheduled for HTO
- •Localized, activity-related knee pain· Varus alignment
- •Medial unicompartmental degenerative osteoarthritis
- •No significant patellofemoral symptoms
- •A ligamentously stable knee
- •Fixed flexion of <5°
排除标准
- •Advanced patellofemoral osteoarthritis
- •Osteoarthritic involvement of the lateral compartment
- •A decreased range of motion less than 90° and a flexion deformity that exceeds 10°
- •Knee ligament instability
- •Active drug or alcohol use or dependence that, in the opinion of the site investigator, that would interfere with adherence to study requirements
- •Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy
- •Inability of patient to speak, read or understand English
- •Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
结局指标
主要结局
The primary outcomes are the fixation stability of the implant
时间窗: 2 years
次要结局
- Validated disease specific outcome measures(2 years)