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Recruiting NCT03481010

NCT03481010 Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

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Clinical Trial Summary
NCT ID NCT03481010
Status Recruiting
Phase —
Sponsor Ottawa Hospital Research Institute
Condition Hip Dysplasia
Study Type INTERVENTIONAL
Enrollment 204 participants
Start Date 2018-04-04
Primary Completion 2030-07-31

Eligibility & Interventions

Sex All sexes
Min Age 16 Years
Max Age 50 Years
Study Type INTERVENTIONAL
Interventions
PAO with hip arthroscopyPAO without hip arthroscopy

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 204 participants in total. It began in 2018-04-04 with a primary completion date of 2030-07-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone. This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time.

Eligibility Criteria

Inclusion Criteria: * Skeletally mature patient undergoing Bernese periacetabular osteotomy for symptomatic acetabular dysplasia/hip instability * Pre-Operative MRI at 3T and/or gadolinium MR arthrogram * Age, 16-50 years old * Patient capable of giving informed consent Exclusion Criteria: * Prior hip/pelvis surgery of any kind on the surgical side * Prior hip arthroplasty surgery on either side * Radiographic evidence of arthritis (i.e. Tönnis grade =2) * Known connective tissue disorder (e.g. Ehlers-Danlos Syndrome, etc.) * Known neuromuscular disorder (e.g. Cerebral Palsy, Spina bifida, etc.) * Known skeletal dysplasia (e.g. Achondroplasia, Multiple Epiphyseal Dysplasia, etc.) * Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires. * Patient unable/unwilling to complete all required follow-up visits * Concurrent proximal femoral osteotomy and/or surgical hip dislocation

Contact & Investigator

Central Contact

Geoffrey Wilkin, MD

✉ gwilkin@toh.ca

📞 613-798-5555

Principal Investigator

Geoffrey Wilkin, MD

PRINCIPAL INVESTIGATOR

Ottawa Hospital Research Institute

Frequently Asked Questions

Who can join the NCT03481010 clinical trial?

This trial is open to participants of all sexes, aged 16 Years or older, up to 50 Years, studying Hip Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03481010 currently recruiting?

Yes, NCT03481010 is actively recruiting participants. Contact the research team at gwilkin@toh.ca for enrollment information.

Where is the NCT03481010 trial being conducted?

This trial is being conducted at Chicago, United States, Royal Oak, United States, St Louis, United States, New York, United States and 3 additional locations.

Who is sponsoring the NCT03481010 clinical trial?

NCT03481010 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Geoffrey Wilkin, MD at Ottawa Hospital Research Institute. The trial plans to enroll 204 participants.

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