Treatment of Hallux Rigidus (HARD): A Prospective, Randomised, Controlled Trial of Arthrodesis Versus Watchful Waiting in the Treatment of Hallux Rigidus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain during walking in Numerical Rating Scale (NRS)
研究概览
简要总结
A randomised, controlled trial will be performed by allocating 40 years or older patients with symptomatic hallux rigidus to arthrodesis or watchful waiting group in a ratio of 1:1. Our primary outcome will be pain during walking, assessed by the 0-10 Numeric Rating Scale (NRS) at one year after randomisation. Our secondary outcomes will be pain in rest (NRS), physical function (MOXFQ), patient satisfaction in terms of Patient-accepted Symptom State (PASS), health-related quality of life (EQ-5D-5L), activity level (The Foot and Ankle Ability Measure Sports subscale), use of analgesics or orthoses and rate of complications. Our null hypothesis is that there will be no difference between arthrodesis and watchful waiting in treatment of hallux rigidus. Our primary analysis will be done using intention-to-treat principle.
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 (Outcomes Assessor)
盲法说明
To avoid biased interpretation of the trial data, blinded data interpretation will be used in the reporting of the results of this trial (70). Before accessing the primary outcome data, the writing committee will record a 'Background assumptions' document containing our definition of MID of the outcome measures, and a brief summary of the key statistical analysis used in the evaluation of the outcome data. The document will be signed by the members of the writing committee and published as an appendix to the primary publication.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or over
- •Diagnosis of hallux rigidus: Persistent pain on movement of the first MTPJ AND Osteoarthritic first MTPJ in plain X-rays
- •Duration of symptoms ≥1 year
- •Pain-NRS during walking of 4 or more on a scale 0-10 (higher is worse)
- •No substantial pain in other joints of the foot in clinical examination
- •Willingness to accept both treatment options
- •Ability to understand trial information and answer outcome assessments in Finnish
- •Signed informed consent
排除标准
- •ASA* physical status classification level III or higher
- •Patients with weak co-operation (dementia, schizophrenia, etc.)
- •Patients with neuropathy, i.e. unable to feel 10g monofilament pressure in less than 8 out of 10 standard testing sites
- •Active bacterial infection or ulcer of the lower limb
- •Diabetes mellitus with insulin treatment
- •Diabetes mellitus and GHb-A1C >64 mmol/mol (regardless of treatment)
- •History of rheumatoid arthritis, gout or other inflammatory arthritis of the foot
- •Hallux valgus angle >15° in weight-bearing X-ray
- •Hallux varus in weight-bearing X-ray
- •Large bone cysts in X-ray probably requiring bone grafting in surgery
- •Pain in passive manipulation of ipsilateral first toe IP joint
- •Patients with severe circulatory disorder of the lower limb: absence of palpable pulses in the foot (both dorsalis pedis artery and tibialis posterior artery)
- •History of surgery of the foot in question
- •Neuropathic pain of the foot in question (i.e., use of neuropathic analgesics)
- •Activity limiting symptoms from an earlier fracture or ligament injury of the foot
- •Patient is not willing to accept the operation within the planned time limits (3 to 12 weeks post-randomisation)
结局指标
主要结局
Pain during walking in Numerical Rating Scale (NRS)
时间窗: 1 year after randomisation
scale 0-10; 0=no pain, 10=worst pain
次要结局
- Pain during rest in Numerical Rating Scale (NRS)(6 months, 1year, 2 years, 5 years)
- Complications(6 months, 1year, 2 years, 5 years)
- Patients physical activity(6 months, 1year, 2 years, 5 years)
- Use of analgesics and orthoses(6 months, 1year, 2 years, 5 years)
- Patient reported quality of life(6 months, 1year, 2 years, 5 years)
- Patient Acceptable Symptom State(6 months, 1year, 2 years, 5 years)
- Patient Related Outcome(6 months, 1year, 2 years, 5 years)
- Pain during walking in Numerical Rating Scale (NRS)(6 months, 2 years, 5 years)
研究者
Mikko Miettinen
Consultant orthopaedic surgeon, M.D.
Hospital District of Helsinki and Uusimaa