Mild Hip Dysplasia

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03530878

Collaborator

(none)

Enrollment

Arms

7.4

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Dysplasia	Procedure: Hip Arthroscopy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Jan 11, 2019

Actual Study Completion Date :

Jan 11, 2019

Arms and Interventions

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.

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)

Outcome Measures

Primary Outcome Measures

The Forgotten Joint Score-12 (FJS-12) [1 year]
Outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Rafael J Sierra, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Rafael J. Sierra, M.D., Professor of Orthopedics, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03530878

Other Study ID Numbers:

17-007229

First Posted:

May 21, 2018

Last Update Posted:

Feb 26, 2019

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hip Dislocation

Developmental Dysplasia of the Hip

Hip Dislocation, Congenital

Study Results

No Results Posted as of Feb 26, 2019