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Clinical Trials/EUCTR2014-003412-37-GB
EUCTR2014-003412-37-GB
Active, not recruiting
Phase 1

Improving outcomes for patients with hip osteoarthritis: a randomised controlled trial - Hip Injection Trial (HIT)

Keele University0 sites348 target enrollmentAugust 22, 2019

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Keele University
Enrollment
348
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 22, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Male or female aged \= 40 years
  • 2\. A clinical diagnosis of unilateral or bilateral hip OA, and confirmed on plain radiography within the last 2 years, as made by a trained clinician in the musculoskeletal service
  • 3\. Moderate to severe current hip pain (a score of 4 or more on a 0\-10 numeric rating scale)
  • 4\. Symptom duration of episode of at least 6 weeks
  • 5\. Hip pain occuring on most days of the last month
  • 6\. Informed written consent provided by the patient
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 116

Exclusion Criteria

  • Participants with the following characteristics are ineligible for the trial:
  • 1\. Hip pain due to other disorders (e.g. trochanteric bursitis, avascular necrosis, pain referred from back)
  • 2\. Intra\-articular corticosteroid injection into the affected hip or ipsilateral trochanteric bursa injection within the proceding 3 months
  • 3\. Any previous surgery on the affected hip
  • 4\. Clinical suspicion of local or systemic sepsis or infection
  • 5\. Current or previous infection of the affected hip
  • 6\. Significant trauma to the affected hip requiring immobilisation in the previous 3 months
  • 7\. Unwillingness to undergo study interventions
  • 8\. Unable to understand and complete self report questionnaires written (or spoken) in English
  • 9\. Significant illness (known or suspected) including, but not limited to:

Outcomes

Primary Outcomes

Not specified

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