Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 8
- 主要终点
- Compare the functional recovery of the shoulder at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results.
研究概览
简要总结
In the context of rotator cuff re-intervention, the impact of Unexpected Positive Cultures (UPC) is not documented, and their management has not been studied, particularly regarding indications for antibiotic therapy, which is currently not a consensus.
A prospective interventional study will be implemented to compare the results of non-randomized patient samples, whether positive or negative, taken during rotator cuff re-intervention. The objective is to assess whether these samples do not affect clinical outcomes and tendon healing rates.
详细描述
Rotator cuff injuries are a common pathology with a 30% prevalence in the general population. If rotator cuff repair fails, patients often experience persistent pain, and bacteria can be detected during the revision period in approximately 30% of cases, even in the absence of septic symptoms. This type of infection, referred to as low-level infection, occurs in around 5% of cases and is frequently implicated as a contributing factor to poor outcomes of the intervention.
Bacteriological samples are routinely collected during revisions, especially for prostheses. The appropriate course of action in cases where these samples test positive, yet there are no signs of infection, remains to be clarified. Notably, administering antibiotics in response to unexpected positive cultures (UPC) during the revision period for total shoulder prostheses does not appear to significantly impact results or infection rates.
In the context of rotator cuff re-interventions, the impact of UPC has not been well-documented. The management of UPC, particularly regarding antibiotic therapy, has not been thoroughly studied and is not currently recommended. Further research is needed to establish guidelines for managing positive cultures in the absence of infection symptoms during rotator cuff re-interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Following the analysis of the bacteriological samples, the investigator will read the bacteriological results. These will be entered into the database.
During subsequent visits, the investigator will not provide this information to the patient who will thus remain as a single blind.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, aged 18 or over
- •Patient requiring re- intervention for Rotator Ruff Revision Surgery for non-healing of the same tendons after a first intervention (delay <2 years)
- •Patient requiring arthroscopy
- •Patient having had realized a MRI of the shoulder in the 6 previous months
- •Affiliate participant or beneficiary of a social security scheme
- •Participant having been informed and not having objected to the use of their data
排除标准
- •Patient with at least one clinical sign of infection (fever, redness)
- •Patient with a new distant rupture on a healed cuff (> 3 years)
- •Patient with a history of shoulder surgery other than initial Rotator Ruff Surgery
- •Patient having received antibiotic treatment in the 2 weeks preceding inclusion
- •Participant in another research
- •Participant in a period of exclusion from another research still in progress at the time of inclusion
- •Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Pregnant, breastfeeding or parturient woman
- •Participant hospitalized without consent
研究组 & 干预措施
Experimental group
Operated patients with positive results for their pre-operative microbiological samples.
干预措施: This study is with minimal risk and minimal constraints due to the addition of questionnaires (Other)
Control group
Operated patients with negative results for their pre-operative microbiological samples.
干预措施: This study is with minimal risk and minimal constraints due to the addition of questionnaires (Other)
结局指标
主要结局
Compare the functional recovery of the shoulder at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results.
时间窗: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the functional recovery (Yes/No), at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results using the Constant Score.
Compare the 2 groups on the occurrence of post-operative complications, after iterative repair of non-healing of the rotator cuff
时间窗: up to one year after the re-intervention
Compare the 2 groups on the occurrence of post-operative complications (Yes/No), after iterative repair of non-healing of the rotator cuff and list them
Compare the 2 groups on tendon healing, after iterative repair of non-healing of the rotator cuff
时间窗: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the 2 groups on tendon healing (Yes/No), after iterative repair of non-healing of the rotator cuff using the Constant Score.
Compare the 2 groups on the patient's other functional scores
时间窗: at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
Compare the 2 groups on the patient's other functional scores such as SSV and ASES questionnaries
Describe the pathogenic germs found in the positive cultures
时间窗: at Month 1 after the re-intervention
List of pathogenic germs found in the positive samples
次要结局
- Functional scores at one year: American Shoulder and Elbow Surgeons Score (ASES)(at one year after the re-intervention)
- Functional scores at one year: Subjective Shoulder Value (SSV)(at one year after the re-intervention)
- Pathogenic bacteria detected in the group of patients with positive results(at Month 1 after the re-intervention)
- Sugaya score measured from MRI to assess the influence of positive cultures on tendon healing(at one year after the re-intervention)
- Occurrence of complications during the first post-operative year(up to one year after the re-intervention)