Clinical Trial of Concomitant Hip Arthroscopy During PAO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-23

Study Completion Date

2028-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will assess the outcomes of patients treated with concomitant hip arthroscopy at the time of periacetabular osteotomy (PAO) for patients with hip dysplasia compared with patients treated with PAO alone.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy

NCT02790749

Hip Dysplasia

UNKNOWN NA

Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

NCT03481010

Hip Dysplasia

RECRUITING NA

Mild Hip Dysplasia

NCT03530878

Hip Dysplasia

WITHDRAWN NA

A Randomized Study of Approaches in Total Hip Arthroplasty

NCT01613508

Total Hip Replacement

COMPLETED NA

Prospective Cohort Study of Arthroscopic Treatment of Hip Dysplasia

NCT06512506

Developmental Dysplasia of the Hip

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There are currently no absolute indications for intraarticular assessment at the time of periacetabular osteotomy (PAO). Based on investigators' review of the literature and experience, patients who may benefit from intraarticular assessment are those with radiographic or MRI evidence of damage where an intraarticular inspection may help in determining whether a PAO is a reasonable procedure, those with mechanical symptoms likely related to labral pathology, round ligament or cartilage problems and those with hip dysplasia and cam deformities with limited range of motion that may benefit from femoral head neck junction osteochondroplasty. However, despite these relative indications today there is no clear evidence to suggest that these patients will do better than those that do not have intraarticular work done. Hence, the objective of this project is to determine whether intraarticular work at the time of PAO surgery leads to improved pain and function when compared to patients that do not undergo intraarticular work at the time of PAO.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Dysplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients will be randomized in a 1:1 fashion. The first arm will be the "PAO alone" group who will receive a standard periacetabular osteotomy (PAO) on the day of surgery. The second arm will be the "PAO + HA" group who will receive a PAO and hip arthroscopy (HA) on the day of surgery. Any pathology if present that can be corrected with the arthroscope (cartilage and labral abnormalities) will be addressed. This will be followed by a standard PAO. Patients from both groups will have dressings placed in the location of hip arthroscopy portals to remain blinded to the treatment arm during the perioperative period. Only patients in the PAO + HA group will have incisions and sutures under these dressings. The dressings will come off for all patients after 2 weeks, which is standard of care. All other study team members will remain unblinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Periacetabular osteotomy

Standard periacetabular osteotomy on the day of surgery.

Group Type EXPERIMENTAL

Periacetabular osteotomy

Intervention Type PROCEDURE

The Bernese periacetabular osteotomy has become the osteotomy of choice in North America for correction of the dysplastic hip. The ability to position the acetabular component in a specifically desired position for each individual patient improves joint biomechanics, restores joint balance and stability, and offloads the structures at risk for damage such as the labrum and the adjacent articular cartilage.

Periacetabular osteotomy with hip arthroscopy

Hip arthroscopy on the day of surgery, followed by a standard periacetabular osteotomy.

Group Type ACTIVE_COMPARATOR

Periacetabular osteotomy with hip arthroscopy

Intervention Type PROCEDURE

An intraarticular assessment with hip arthroscopy (HA) at the time of periacetabular osteotomy allows the surgeon to assess and treat the associated labral and chondral pathology and allows the surgeon to treat abnormalities of the femoral head junction.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Periacetabular osteotomy

The Bernese periacetabular osteotomy has become the osteotomy of choice in North America for correction of the dysplastic hip. The ability to position the acetabular component in a specifically desired position for each individual patient improves joint biomechanics, restores joint balance and stability, and offloads the structures at risk for damage such as the labrum and the adjacent articular cartilage.

Intervention Type PROCEDURE

Periacetabular osteotomy with hip arthroscopy

An intraarticular assessment with hip arthroscopy (HA) at the time of periacetabular osteotomy allows the surgeon to assess and treat the associated labral and chondral pathology and allows the surgeon to treat abnormalities of the femoral head junction.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of hip dysplasia (DDH) electing periacetabular osteotomy (PAO) for treatment
* Skeletally mature
* Age 15 - 55
* Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis)
* Ability to receive a standard of care preoperative (magnetic resonance imaging) MRI arthrogram of the hip

Exclusion Criteria

* Pregnant women
* Previous surgery about the hip
* Patients receiving PAO for acetabular retroversion in the absence of DDH
* Previous hip arthroscopy to address intra-articular pathology

Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No