Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy

NCT02790749 | Unknown

• 1 other identifier: 1603903
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although evidence is amassing regarding the role of intra-articular pathology in the surgical management of adolescents and adults with hip dysplasia, the optimal method of detection and especially management of this pathology remains unclear. No studies exist to compare clinical outcomes and hip survival between arthroscopy and arthrotomy in patients with mechanical hip pain undergoing periacetabular osteotomy (PAO) for dysplasia, and this is what the investigators aim to achieve in the current prospective randomized surgical trial.

Conditions

Hip Dysplasia

Keywords

Developmental hip dysplasia; Intra-articular pathology; Adult hip dysplasia; Labral tear, hip; Chondromalacia, hip

Outcome Measures

Primary Outcomes (2)

• Incidence of reoperation by final follow-up

  Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO

  One year

• NAHS (non-arthritic hip score)

  Absolute value of, and measure of post-operative improvement in, validated questionnaire known as NAHS--Non-Arthritic Hip Score

  One year

Secondary Outcomes (3)

• iHOT-12: 12-question version of the international Hip Outcome Tool

  one year

• HOS: Hip Outcome Score

  one year

• mHHS: Modified Harris Hip Score

  one year

Study Arms (2)

PAO with adjunctive hip arthroscopy

EXPERIMENTAL

Patients undergoing periacetabular osteotomy (PAO) with adjunctive hip arthroscopy.

Procedure: Adjunctive hip arthroscopy to accompany PAO

PAO WITHOUT adjunctive hip arthroscopy

ACTIVE COMPARATOR

Patients undergoing periacetabular osteotomy (PAO) WITHOUT adjunctive hip arthroscopy.

Procedure: PAO without adjunctive hip arthroscopy

Interventions

Adjunctive hip arthroscopy to accompany PAO PROCEDURE

This is the experimental group: those patients who undergo adjunctive hip arthroscopy in addition to periacetabular osteotomy (PAO).

PAO with adjunctive hip arthroscopy

PAO without adjunctive hip arthroscopy PROCEDURE

This is the control group: those patients who undergo periacetabular osteotomy (PAO) alone, without adjunctive hip arthroscopy.

PAO WITHOUT adjunctive hip arthroscopy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18 to 50
• Moderate or severe dysplasia by radiographic parameters
• English- or Spanish-speaking
• signed written informed consent for surgery and for research prior to surgery

You may not qualify if:

• Tönnis grade II or III arthritis at baseline
• MR cartilage imaging indicating severe arthritis
• Prior surgery on the same hip
• Contralateral lower limb pathology that threatens validity of outcomes measures directed at the operative hip
• History of thromboembolic disease in the lower extremity, pulmonary embolus, or pre-existing thrombophilic blood disorder
• Inability to participate in or comply with appropriate rehabilitation protocols
• Inability to comprehend and follow instructions, or mental incapacity barring consent
• Pregnant women
• Lost to follow-up before one year, unless total hip replacement performed before one year (then included for survival analysis)

Sponsors & Collaborators

• Sharp HealthCare: lead

Related Publications (33)

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  BACKGROUND

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  PMID: 22058293 BACKGROUND

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  PMID: 24843847 BACKGROUND

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MeSH Terms

Conditions

Hip Dislocation; Developmental Dysplasia of the Hip; Cartilage Diseases

Interventions

Polyamine Oxidase

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oxidoreductases Acting on CH-NH Group Donors; Oxidoreductases; Enzymes; Enzymes and Coenzymes

Study Officials

• Michael P Muldoon, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael P Muldoon, MD

CONTACT

8582788300; mpmuldoon@cox.net

Gregory M Gosey, MD, MAS

CONTACT

3037484337; ggosey@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 6, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: June 6, 2016

Record last verified: 2016-05