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临床试验/NCT03530878
NCT03530878撤回不适用

Periacetabular Osteotomy Versus Arthroscopic Management of Mild Hip Dysplasia: A Randomized Clinical Trial

Mayo Clinic0 个研究点开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
主要终点
The Forgotten Joint Score-12 (FJS-12)

研究概览

简要总结

Hip dysplasia is a complex problem that exists on a spectrum from mild to severe disease. Periacetabular osteotomy (PAO) remains the gold standard for most patients with dysplasia; however, the procedure is quite invasive making the decision to proceed in cases of mild disease difficult. Hip arthroscopy (HA) is an alternative minimally invasive technique that can be used to address mild dysplasia. Nevertheless, HA has less capability for correction and in rare instances can exacerbate instability in the dysplastic hip. There is a paucity of data examining outcomes between these two treatment strategies for this challenging problem.

详细描述

The Bernese periacetabular osteotomy (PAO) remains the gold standard for treatment of symptomatic developmental dysplasia of the hip (DDH) in most patients with closed triradiate cartilage. First developed by Ganz in 1984, this technique utilizes 4 osteotomies to completely mobilize the acetabular fragment 1. Although a technically demanding procedure, it allows optimal correction in all planes and maintains integrity of the posterior column, enabling early weight bearing and mobilization. Several groups have confirmed the long-term efficacy of this joint preservation procedure with a recent report from the inventing institution documented impressive survivorship up to 30 years after surgery 2. Treatment with PAO is more controversial for mild forms of dysplasia where the lateral center-edge angle (LCEA) is 18° - 25° and/or the Tӧnnis angle is 8° - 15°. In these patients the delta correction is more limited, thus creating a more unpredictable result with equally invasive surgery.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of symptomatic mild DDH
  • Lateral center-edge angle 18° - 25° and/or Tӧnnis angle 8° - 15°
  • Skeletally mature
  • Age 18 - 45
  • Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis)
  • Ability to receive a standard of care preoperative MRI arthrogram of the hip

排除标准

  • Pregnant women
  • Neurogenic dysplasia
  • Legg-Calvé-Perthes disease
  • Previous surgery about the hip including previous hip arthroscopy to address intra-articular pathology

研究组 & 干预措施

Hip Arthroscopy (HA)

Experimental

This approach addresses intraarticular pathology in the form of labral tears and cartilage that are often concomitant with DDH 3. Furthermore, capsular plication can be performed through HA to reduce instability of the joint.

干预措施: Hip Arthroscopy (Procedure)

Periacetabular Osteootmy (PAO)

No Intervention

The Bernese periacetabular osteotomy (PAO) remains the gold standard for treatment of symptomatic developmental dysplasia of the hip (DDH) in most patients with closed triradiate cartilage. First developed by Ganz in 1984, this technique utilizes 4 osteotomies to completely mobilize the acetabular fragment 1. Although a technically demanding procedure, it allows optimal correction in all planes and maintains integrity of the posterior column, enabling early weight bearing and mobilization.

结局指标

主要结局

The Forgotten Joint Score-12 (FJS-12)

时间窗: 1 year

Outcome

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rafael J. Sierra, M.D.

Professor of Orthopedics

Mayo Clinic

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