Mild Hip Dysplasia

Hip Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03530878
• Other study ID #: 17-007229
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 11, 2019

Study information

• Verified date: February 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 11, 2019
• Est. primary completion date: January 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Diagnosis of symptomatic mild DDH

• Lateral center-edge angle 18° - 25° and/or T?nnis 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

Related Conditions & MeSH terms

• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia

Intervention

Procedure:
• Hip Arthroscopy
Intraarticular pathology in the form of labral tears and cartilage that are often concomitant with DDH

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Forgotten Joint Score-12 (FJS-12)	Outcome	1 year

External Links

•   Mayo Clinic Clinical Trials