Modifications of Devices for Hip Arthroscopy

University of Colorado Denver (CU Denver)

Status: Invitation-only

Conditions: Hip Arthroscopy

Treatments: Device: Modified bone graft delivery tool set; Device: Modified hip capsule side fixed slotted cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT04516109

19-2755

Details and patient eligibility

About

This is protocol is intended to demonstrate the principal investigator's improvements and modifications of a hip capsule side fixed slotted cannula for continued access to the hip joint and a bone graft delivery tool set for grafting subchrondral cysts during hip arthroscopy procedure.

Full description

Femoroacetabular impingement (FAI) and acetabular dysplasia represent the two most common causes of secondary osteoarthritis of the hip1-3 and the two main indications for Hip Preservation procedures. Most patients with these pathologies will undergo Hip Arthroscopy, either alone, or combined with bony realignment procedures. Hip arthroscopy has grown exponentially over the past 15 years and is currently being leveraged in the diagnosis and treatment of a wide range of hip joint problems.

In an effort to improve surgical techniques, make surgeries faster and reproducible, mitigate complications and increase patient safety, surgeons modify and improve commercially available and commonly used non-significant risk devices with the above goals in mind.

For these reasons, the Principal Investigator (PI) modified and improved two devices for hip arthroscopy. These include the modified (1) hip capsule side fixed slotted cannula for continued access to the hip joint and (2) bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure. After utilizing these modified devices clinically, the PI has been impressed with their impact and thus aims to demonstrate that the modifications provide significant improvements in surgical flow and technique, minimize surgical time (per technical phase), minimize surgical costs, result in an absolute low incidence of surgical complications, and ultimately improve patient outcomes.

Enrollment: 111 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females between the ages of 18 and 60 years diagnosed with FAI, Hip Dysplasia or the combination of the two.
• Persistent hip pain accompanied by mechanical symptoms refractory to nonoperative management lasting at least 3 months.
• Reproducible clinical examination findings suggestive of impingement and/or decreased range of motion, and positive radiographic findings on radiography, computed tomography with 3-dimensional reconstruction, and magnetic resonance imaging.
• Joint-space width > 3 mm on all views of plain radiography and 3-dimensional computed tomography.
• Patients undergoing hip arthroscopy for the treatment of FAI, Hip Dysplasia, or the combination of the two by the Principal Invesitgator.

Exclusion criteria

• Age <18 years.
• Prisoners.
• Pregnant women.
• Decisionally challenged.
• Does not speak or understand English.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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111 participants in 2 patient groups

Arthrosocpic labral repair

Active Comparator group

Description:

Patients undergoing arthroscopic labral repair with the use of the modified hip capsule slotted cannula.

Treatment:

Device: Modified hip capsule side fixed slotted cannula

Arthroscopic bone grafting

Active Comparator group

Description:

Patients undergoing arthroscopic bone grafting of subchrondral cyst with the use of the modified bone graft delivery tool set and modified hip capsule slotted cannula.

Treatment:

Device: Modified bone graft delivery tool set

Device: Modified hip capsule side fixed slotted cannula