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Viscosupplementation in the Hip Following Hip Arthroscopy

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ClinicalTrials.gov Identifier: NCT02476903
Recruitment Status : Unknown
Verified June 2015 by Rothman Institute Orthopaedics.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2015
Last Update Posted : June 22, 2015
Sponsor:
Collaborator:
Sean McMillan, DO
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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


Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Monovisc Not Applicable

Study Type : Interventional  (Clinical Trial)
Official Title: Viscosupplementation in the Hip Following Hip Arthroscopy
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Pain Using Visual Analog Scale [ Time Frame: Up to 12 months ]
    Using Visual Analog Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT02476903     History of Changes
Other Study ID Numbers: 2015Salvo
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases