Surgery for Patellofemoral Instability, is There Normal Gait
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of participants with abnormal gait who have patellar instability
研究概览
简要总结
The principal objective of the study is to find out which everyday activities make the kneecap unstable in people with patellofemoral instability.
Analysing how a patient with an unstable kneecap walks will help us to determine if surgery is successful in these patients by seeing if better scores on patient questionnaires are found in patients following surgery and whether these patients also have a better pattern of walking.
The investigators aim to use cameras and pressure pads to see how patients walk before and after surgery and see how this compares to patient scores on the questionnaires.
If the investigators find that patients walk better after surgery they can justify that surgery is worthwhile for the patient and cost effective for the NHS.
详细描述
Recruitment strategy:
Patients referred to a specialist patellofemoral clinic with an unstable kneecap(s) will be approached by the student and asked whether they would be interested in participating in the study (study group). Participants will be considered eligible for the study group if they have had two or more episodes of kneecap dislocation or many episodes of instability with at least one of the following: a feeling that the kneecap will dislocate with pressure, tenderness along the inner side of the knee and/or abnormal movement or position of the kneecap.
They will be given a Patient Information Sheet (PIS) and be given time during the clinic to ask questions about the study. During this first appointment as per routine current clinical practice they will have an X-ray of their knee and fill in standard questionnaires to score their knee function and pain (Norwich Patellofemoral Instability score, Kujala score, PainDetect score, catastrophising score). The patient's knees will also be examined by the consultant and a record made of the clinical findings. As per routine practice, a magnetic resonance imaging (MRI) scan of both knees will be organised for 4 weeks after the original appointment and measurements of knee shape recorded. A total of 32 patients will be invited to join the study to assess the movement of the kneecap in patients with kneecap instability.
A group of normal knees (control group) will be studied to compare the findings from students aged 18 to 50 years at St George's University of London allowing both age and gender to be matched to the study group . Students with no previous history of knee problems will be eligible to join the control group.
Inclusion criteria for both groups includes age 18-50 years, English language speakers, able to use public transport or drive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient subjects will be considered eligible for the study group if they have had two or more episodes of patellar dislocation or multiple episodes of subluxation with at least one of the following:
- •Positive patellar apprehension test
- •Tenderness along the medial retinaculum
- •Abnormal patellar tracking or position
- •Control participants should be healthy subjects with no history of knee injury or surgery
- •All participants will need to have the capacity to give informed consent in English
- •All participants must be able to use public transport or drive
排除标准
- •Pregnancy
- •Breast feeding
- •Arthritis
- •Participation in other studies
结局指标
主要结局
Number of participants with abnormal gait who have patellar instability
时间窗: Before surgery
Graphical measurement of raw kinematic data to include joint moments at ankle, knee and hip comparing patients with patellar instability to normal controls
次要结局
- Number of patients with a change in patellar pressure at the time of surgery to correct patellar instability(during surgery)
- Number of patients with normal gait 6 months after surgery to correct patellar instability(6 months)
- Number of patients with normal ground reaction force 6 months after surgery to correct patellar instability(6 months)
- Number of patients who have an abnormal EMG compared to normal controls(before surgery)
- Number of patients with a change in EMG 6 months after surgery to correct patellar instability(6 months)
- Number of patients with a change in patellar tracking at the time of surgery to correct patellar instability(during surgery)