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Viscosupplementation in the Hip Following Hip Arthroscopy

Primary Purpose

Osteoarthritis

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Monovisc

About this trial

This is an interventional trial for Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Preoperative inclusion criteria will be made via x-ray and MRI evaluation. These criteria shall include: 2 mm or greater joint space preservation of the hip on radiographs, absence of acetabular subcortical bone cysts, Tonnis Score less than 2 on radiographs, and patient age greater than 18.4 Intra-operative evaluation of the cartilage will be performed by the surgeon on both the acetabular and femoral head sides. Patients shall be included if the osteochondral defect meets Outerbridge Classification criteria of stage II or greater. Furthermore the lesion shall be greater than 1cm in size (and thus not amenable to other procedures such as microfracture). Subjects must be willing to sign the IRB-approved informed consent and be older than 18 years old.

Exclusion Criteria:

All patients 55 years of age and older. All patients with previous hip surgery on a concomitant side. Patients who present a history of radiculopathy or regional pain syndrome. Patients with a worker's compensation claim or pending litigation claim. Patients with Outerbridge Grade IV changes on either acetabular or femoral articular cartilage.

Sites / Locations

Outcomes

Primary Outcome Measures

Pain Using Visual Analog Scale

Using Visual Analog Scale

Secondary Outcome Measures

Full Information

NCT ID

NCT02476903

First Posted

June 17, 2015

Last Updated

June 19, 2015

Sponsor

Rothman Institute Orthopaedics

Collaborators

Sean McMillan, DO

1. Study Identification

Unique Protocol Identification Number

NCT02476903

Brief Title

Viscosupplementation in the Hip Following Hip Arthroscopy

Official Title

Viscosupplementation in the Hip Following Hip Arthroscopy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rothman Institute Orthopaedics

Collaborators

Sean McMillan, DO

4. Oversight

5. Study Description

Brief Summary

Hip arthroscopy is a rapidly evolving procedure that has seen an exponential increase in the number of cases performed yearly. With hip arthroscopy still in its infancy in relation to knee and shoulder arthroscopy, there are still many questions yet to be answered. Axioms that were once thought to be true regarding indications and treatment for hip arthroscopy are continually being revised. As with the knee and shoulder before it, the hip is now graduating into treatment avenues that were otherwise thought to only be possible through an open surgical procedure. Viscosupplementation in patients post arthroscopy with known articular cartilage injury has been shown to be efficacious. The pathophysiology of hyaline degradation during the arthritic process within the knee has been studied, and with this understanding has grown the widespread usage of viscosupplementation. While questions still exist regarding the effectiveness of viscosupplementation in non-weightbearing joints, it appears the benefits seen in the weight bearing joints, such as the knee, are apparent

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Monovisc

Primary Outcome Measure Information:

Title

Pain Using Visual Analog Scale

Description

Using Visual Analog Scale

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Preoperative inclusion criteria will be made via x-ray and MRI evaluation. These criteria shall include: 2 mm or greater joint space preservation of the hip on radiographs, absence of acetabular subcortical bone cysts, Tonnis Score less than 2 on radiographs, and patient age greater than 18.4 Intra-operative evaluation of the cartilage will be performed by the surgeon on both the acetabular and femoral head sides. Patients shall be included if the osteochondral defect meets Outerbridge Classification criteria of stage II or greater. Furthermore the lesion shall be greater than 1cm in size (and thus not amenable to other procedures such as microfracture). Subjects must be willing to sign the IRB-approved informed consent and be older than 18 years old. Exclusion Criteria: All patients 55 years of age and older. All patients with previous hip surgery on a concomitant side. Patients who present a history of radiculopathy or regional pain syndrome. Patients with a worker's compensation claim or pending litigation claim. Patients with Outerbridge Grade IV changes on either acetabular or femoral articular cartilage.

12. IPD Sharing Statement

Learn more about this trial

Viscosupplementation in the Hip Following Hip Arthroscopy

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