Arthroscopic Versus Open Brostrom for Ankle Instability: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- Complications (change)
研究概览
简要总结
Background: Ankle sprains are among the most prevalent lesions in primary care. A substantial number of these ligament lesions will develop ankle instability and require a surgical procedure. The Brostrom-Gould technique is the standard surgical approach for this condition, providing excellent results over the years. Thru the last decades, the arthroscopic Brostrom has gain popularity and support by several studies. Yet, there is no consensus regarding the best procedure to treat ankle instability nowadays.
Hypothesis: The arthroscopic Brostrom technique will present better levels of pain and function when compared to the standard open approach.
Design: blinded, in parallel groups, multicentric, randomized, clinical trial.
Materials and Methods: 98 patients with a diagnosis of chronic ankle instability, referred from primary or secondary health care services, will be assessed and enrolled in this study. Participants will be divided in two groups (randomized by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the open Brostrom repair technique and the other comprehending the arthroscopic Brostrom approach. The assessments will occur in 3, 6, 12, 24 and 48 weeks. Patients will be evaluated primarily by complications and secondarily the Cumberland Ankle Instability Tool (CAIT), American Orthopedic Foot and Ankle Society (AOFAS), the Visual Analogue Scale (VAS), the Foot Function Index (FFI) and the 36 Item Short Form Health Survey (SF-36). The investigators will use Comparison of Two Proportions via relative frequency analysis, the Pearson Correlation the Chi-Square test and the ANOVA for statistical analyses.
Discussion: This study intends to establish if the arthroscopic Brostrom technique can produce excellent and reliable results when treating chronic ankle instability. A shorter surgical time, a better cosmetic appearance and a smaller soft tissue injury would support the choice for this procedure if the outcomes could be compared to the open approach.
详细描述
- Introduction
Ankle sprains are among the most prevalent lesions in the athletic and non-athletic population(1). Accounting to up than 14% of emergency visits and with an estimated year cost of more than U$6 billion, it has a high impact in the health care system(2,3). Approximately 10 to 40% of these cases will develop ankle instability. The most susceptive population are those with an erratic treatment and/or poor rehabilitation program(4). Over the past years, the open Brostrom Gould procedure has been state as the gold standard procedure for this specific group of patients. (5,6). (7,8).
With the development and improvement intra-articular ligament reconstruction and repair for shoulder and knee, the possibility to perform the same type of procedure at the ankle has grown. Arthroscopic-assisted Brostrom techniques were first described by Nery et al and Corte-Real et al near the year 2010(9,10). Some authors proposed modifications to these original approaches, but the main surgery concept was maintained(11-14).. During the last few years, a good number of studies were able to present good clinical and functional results with this procedure(1,11,15-18).
Ankle arthroscopy is a reliable procedure and has been indicated to evaluate and treat a great number of ankle pathologies over the past decades(19,20). Ankle impingement, osteochondral lesions and tibiotarsi arthrodesis are some of the conditions that have good literature support in favor for the arthroscopic approach(21). Also, its use, prior to an ankle ligament repair or reconstruction, is advocated and sustained by several studies(22-26). It allows a complete articular visualization, providing the surgeon with a definitive scenario when dealing with ankle instability. Cartilage lesions, impingement syndromes and loose bodies that could be neglected by subsidiary exams can be detected and treated arthroscopically.
The intra-articular ligament reconstruction and repair is not novelty for others orthopedic areas. The development of the anterior cruciate ligament surgery went to from the open approach to the arthroscopic technique over the last decades until the least was proclaimed the gold standard(27,28). The Bankart lesion, a condition normally related to traumatic shoulder instability, has a similar history, although the arthroscopic approach wasn't able to produce superior general results when compared to its open counterpart (29,30). Advances in the "all-inside" ligament repair are taking place at the shoulder and hip segment as well, showing promising and solid outcomes(31,32).
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)
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
- 否
入选标准
- •Individuals must be older than 18 and younger than 65 years of age, both genders;
- •Participants must be experiencing instability symptoms at the ankle over the last six months;
- •Clinical diagnosis of ankle instability, defined as the presence of at least one previous ankle sprain associated with a current instability sensation by the patient and the presence of a positive anterior drawer test; the previous lateral ligament injury must be confirmed by Magnetic Resonance Imaging (MRI) findings.
排除标准
- •Previous surgery involving the affected foot or ankle;
- •History or documented evidence of autoimmune or peripheral vascular diseases;
- •History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, spondylitis, Reiter Syndrome, etc.);
- •Associated injuries, such as osteochondral lesions, tendon ruptures and fractures.
- •Associated instability, such as syndesmotic and medial instability.
- •Cavovarus foot;
- •BMI over 35;
- •Previous infiltration in the ankle over the six months preceding the initial assessment;
- •Pregnancy;
- •Any condition that represents a contraindication of the proposed therapies;
- •Impossibility or incapacity to sign the informed Consent Form;
- •History or documented evidence of blood coagulation disorders (including treatment with anti-coagulants, but excluding aspirin);
- •Use of heart pacemaker;
- •Presence of infectious process (superficial on skin and cellular tissue, or deep in the bone) in the region to be treated;
结局指标
主要结局
Complications (change)
时间窗: 3, 6, 12, 24 and 48 weeks
* Dehiscence: inability to heal the soft tissue coverage until the end of the 4th post-operative week. * Peripherical nerve damage: hypoesthesia or paresthesia not solved until the end of the 6th month after the surgery. * Infection: clinical signs of site infection or pus drainage at the wound that required the use of antibiotics. * Re-rupture: an ankle sprain event during the follow-up.
次要结局
- American Orthopedic Foot and Ankle Society - AOFAS (change)(3, 6, 12, 24 and 48 weeks)
- 36 Item Short Form Health Survey - SF36 (change)(3, 6, 12, 24 and 48 weeks)
- Minor complications (change)(3, 6, 12, 24 and 48 weeks)
- Foot Function Index - FFI (change)(3, 6, 12, 24 and 48 weeks)
- Cumberland Ankle Instability Tool - CAIT (change)(3, 6, 12, 24 and 48 weeks)
- Visual Analogue Scale - VAS (change)(3, 6, 12, 24 and 48 weeks)
研究者
Nacime Salomão Barbachan Mansur
Principal Investigator
Federal University of São Paulo
