NCT03530878

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

April 9, 2018

Last Update Submit

February 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Forgotten Joint Score-12 (FJS-12)

    Outcome

    1 year

Study Arms (2)

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.

Procedure: Hip Arthroscopy

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.

Interventions

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

Hip Arthroscopy (HA)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Study Officials

  • Rafael J Sierra

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopedics

Study Record Dates

First Submitted

April 9, 2018

First Posted

May 21, 2018

Study Start

June 1, 2018

Primary Completion

January 11, 2019

Study Completion

January 11, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02