Mild Hip Dysplasia

NCT ID: NCT03530878

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-01-11

Brief Summary

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.

Detailed Description

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.

Conditions

Hip Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hip Arthroscopy (HA)

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.

Group Type: EXPERIMENTAL

Hip Arthroscopy

Intervention Type: PROCEDURE

Intraarticular pathology in the form of labral tears and cartilage that are often concomitant with DDH

Periacetabular Osteootmy (PAO)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hip Arthroscopy

Intraarticular pathology in the form of labral tears and cartilage that are often concomitant with DDH

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Rafael J. Sierra, M.D.

Professor of Orthopedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rafael J Sierra

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

17-007229

Identifier Type: -

Identifier Source: org_study_id