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临床试验/NCT04894578
NCT04894578招募中不适用

Can Reverse Oblique Distal Minimal-invasive Osteotomies Replace Arthrodesis of the Tarsometatarsal Joints? - a Prospective, Comparative Trial of 50 Patients

Kantonsspital Baden1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年5月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Clinical Outcome using a patient related outcome measure, the FAAM score (Validated Foot and Ankle Ability Measure). The score is a self-report outcome instrument developed to assess physical function. The change between the time points is measured.

研究概览

简要总结

Group A: Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a reverse distal metatarsal minimal-invasive osteotomy Group B: Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a fusion of one or more midfoot (tarsometatarsal) joints

详细描述

Midfoot arthritis is a common condition leading to disabling chronic foot pain that affects activities of daily living. The causes can be primary osteoarthritis (OA), inflammatory or post-traumatic. We are looking at OA of the lesser (second and/or third) tarsometatarasal joints (TMTJ). Orthotics, customised shoes or steroid injections are options to treat this condition nonoperatively. If these measures fail, arthrodesis of the arthritic joints represents the standard procedure to surgical treatment. Generally, the results of this procedure are at a satisfactory level for the patients, nevertheless, there is a relevant amount of patients with residual pain, lack of a normal foot appearance, and the need for unplanned surgery or use of orthotics postoperatively. Furthermore, patients undergoing an arthrodesis of the lesser TMTJ usually have to stay in hospital for 4-7 days. Postoperatively, patients are only allowed to partially weightbear for at least 6 weeks and need a cast for six weeks as well. During that time thrombosis prophylaxis is administered for about 6 weeks.

The conventional distal minimal-invasive metatarsal osteotomy (DMMO) is an accepted technique for metatarsal osteotomies. Recently, Schneider et al. presented results of a modification of the conventional DMMO, the reverse DMMO to treat OA of the lesser TMTJ, thus representing an alternative treatment to arthrodesis. The procedure has many benefits. It allows outpatient care, an immobilisation in a cast is not necessary. Instead, patients have to wear a flat postoperative shoe for 2-3 weeks and are allowed to fully weightbear from day one after surgery. Therefore, thrombosis prophylaxis is not necessary unless there are specific risk factors.

However, while the arthrodesis directly addresses the arthritic joints, the R-DMMO alters the ground reaction force of the metatarsal head leading to less stress at the level of the TMTJ, but the arthritic joint itself is not approached. Still, the results presented by Schneider et al. are promising. Since there was no group to compare the treatment with, the small sample size, and a retrospective design, we would like to prospectively compare these two surgical procedures directly in order to find out whether or not the R-DMMO can be recommended as a standard procedure for OA of the lesser TMTJ at a much more convenient level for patients regarding the whole perioperative protocol. No vulnerable population is included. The scientific value is remarkable since this would be the first study to examine this matter and we are able to provide a high level of evidence due to the prospective-randomised and comparative design of the study. All legal requirements will be fulfilled and the ethical standards are guaranteed.

Both procedures have been described and the technique of the DMMO itself is not new, but its modification (R-DMMO) represents a new approach for this condition. Both procedures are reliable and safe, which is why the risk category of the study is A according to ClinO, Art. 61.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • •Patients older than 18 years
  • •Midfoot arthritis of lesser TMTJ (second, third, rarely fourth and fifth) with ongoing disabling pain
  • •Able to give informed consent as documented by signature
  • •failed conservative treatment for a period of at least 3 months (CSI injections and/or orthotic devices)

排除标准

  • •Concomitant fusion of 1st TMTJ
  • •Patients younger than 18 years
  • •Contraindication to undergo surgery or general anaesthesia
  • •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  • •pregnancy

研究组 & 干预措施

Group A

Active Comparator

Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a reverse distal metatarsal minimal-invasive osteotomy

干预措施: reverse distal metatarsal minimal-invasive osteotomy (Procedure)

Group B

Active Comparator

Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a fusion of one or more midfoot (tarsometatarsal) joints

干预措施: tarsometatarsal fusion (Procedure)

结局指标

主要结局

Clinical Outcome using a patient related outcome measure, the FAAM score (Validated Foot and Ankle Ability Measure). The score is a self-report outcome instrument developed to assess physical function. The change between the time points is measured.

时间窗: 6 weeks, 3 months, 6 months, 12 and 24 months post surgery

FAAM score, the highest score is 100, indicating the best possible outcome

次要结局

  • Duration of procedure(through study completion, an average of 2 years)
  • Length of hospital stay(through study completion, an average of 2 years)
  • Visual Analogue Scale (VAS) score. It is a measurement instrument for the amount of pain that a patient feels. The score is assessed preoperatively and the change between the time points is measured.(6 weeks, 3 months, 6 months, 12 and 24 months post surgery)
  • Radiological union by evaluating conventional X-Ray. Preoperative X-Rays and postoperative X-Rays are comparted and the change in union in terms of bone densitiy is assessed postoperatively.(6 weeks, 3 months, 6 months, 12 and 24 months post surgery)
  • Complications(6 weeks, 3 months, 6 months, 12 and 24 months post surgery)

研究者

发起方
Kantonsspital Baden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher G Lenz

Principal Investigator

Kantonsspital Baden

研究点 (1)

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