Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years - 50 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03481010
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ottawa Hospital Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Geoffrey Wilkin, MD
Principal Investigator Affiliation The Ottawa Hospital Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hip Dysplasia
Additional Details

Hip dysplasia is a developmental abnormality of the acetabulum (hip socket) that causes abnormal stresses inside the hip joint and leads to painful arthritis at a young age. Many patients develop painful symptoms in their hip before advanced arthritis occurs. The periacetabular osteotomy (PAO) is a surgical procedure that reorients the acetabulum to reduce the stresses inside the hip joint. The PAO is very effective at improving symptoms and quality of life. However, some patients may have residual symptoms. Frequently, people with hip dysplasia will have an MRI done before their surgery, which helps to identify other the abnormalities inside their hip joint (e.g., labral tears). These abnormalities inside the joint cannot easily be addressed through PAO alone, however they can be addressed with hip arthroscopy. Hip arthroscopy is a separate minimally invasive surgical procedure that allows the surgeon to access the inside of the hip joint with a small camera and address any abnormalities. 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. Patients will be followed for 2 years after surgery. Symptomatic differences between the two patient groups will be assessed to determine added benefit of the hip arthroscopy.

Arms & Interventions

Arms

Experimental: PAO with hip arthroscopy

Patient's in the "Scope PAO" group have been diagnosed with hip dysplasia and a decision has been made between the patient and the surgeon that the best way to treat the hip problems is with surgery. Patient's in the "Scope-PAO" group have been randomized to receive a periacetabular osteotomy with a hip arthroscopy.

Active Comparator: PAO without hip arthroscopy

Patient's in the "PAO-only" group have been diagnosed with hip dysplasia and a decision has been made between the patient and the surgeon that the best way to treat the hip problems is with surgery. Patient's in the "PAO-only" group have been randomized to receive a periacetabular osteotomy only.

Interventions

Procedure: - PAO with hip arthroscopy

Participants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO.

Procedure: - PAO without hip arthroscopy

Participants who are randomized to the "PAO-only" group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Michael Stover, MD

[email protected]

613-798-5555

William Beaumont Hospital, Royal Oak, Michigan

Status

Recruiting

Address

William Beaumont Hospital

Royal Oak, Michigan, 48073

Site Contact

Ira Zaltz, MD

[email protected]

613-798-5555

The Washington University, Saint Louis, Missouri

Status

Recruiting

Address

The Washington University

Saint Louis, Missouri, 63130

Site Contact

John C. Clohisy, MD

[email protected]

613-798-5555

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Ernest Sink, MD

[email protected]

613-798-5555

International Sites

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Status

Recruiting

Address

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1

Site Contact

Kevin Smit, MD

[email protected]

613-798-5555

Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Status

Recruiting

Address

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6

Site Contact

Geoffrey Wilkin, MD

[email protected]

613-737-8920

CHU de Québec - Université Laval, Québec, Canada

Status

Recruiting

Address

CHU de Québec - Université Laval

Québec, , G1J 1Z4

Site Contact

Etienne Belzile, MD

[email protected]

613-798-5555