Mild Hip Dysplasia

• ClinicalTrials.gov Identifier: NCT03530878
• Recruitment Status: Withdrawn
• First Posted: May 21, 2018
• Last Update Posted: February 26, 2019
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Rafael J. Sierra, M.D., Mayo Clinic

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	Not Applicable

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 (Clinical Trial)
• 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: June 1, 2018
• Actual Primary Completion Date: January 11, 2019
• Actual Study Completion Date: January 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.

Outcome Measures

Primary Outcome Measures :

1. The Forgotten Joint Score-12 (FJS-12) [ Time Frame: 1 year ]
   Outcome

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Rafael J Sierra; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• 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: February 26, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Musculoskeletal Abnormalities; Congenital Abnormalities