Mild Hip Dysplasia

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hip Dysplasia
• Intervention / Treatment: Procedure: Hip Arthroscopy

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: Hip Arthroscopy; Intraarticular pathology in the form of labral tears and cartilage that are often concomitant with DDH
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Forgotten Joint Score-12 (FJS-12)	Outcome	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Rafael J Sierra, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): January 11, 2019
• Study Completion (ACTUAL): January 11, 2019

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (ACTUAL): May 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 23, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: 17-007229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No