Intra-articular Corticosteroid With Hyaluronic Acid Plus Physiotherapy for Hip Pathologies (NON-OP HIP)

NCT06653985 | Recruiting

• 1 other identifier: nonophip
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Hip pathologies that cause pain and functional limitations are common in the general population. These can include femoroacetabular impingement (FAI), labral tears and mild osteoarthritis (OA) among others. While more severe and symptomatic cases may require surgical intervention, the treatment of mild-to-moderate cases is often treated without surgery to relieve pain, improve function, and delay surgical intervention. Non-operative treatments of hip pathologies consist of a multitude of options. A common non-operative intervention includes intra-articular injections, including corticosteroids and hyaluronic acid. Evidence has demonstrated that corticosteroids have fast acting effects which tend to diminish within a few months, while hyaluronic acid has a delayed time of onset and demonstrates clinical benefit for a longer period of time. Studies have evaluated combinations of corticosteroid and hyaluronic acid, hoping to take advantage of the fast-acting relief of corticosteroid and the longer lasting benefits of corticosteroid. Physiotherapy is also a frequent non-operative intervention used to relieve pain and increase function in patients with hip pathologies. While many studies have looked at intra-articular injections and physiotherapy as independent non-operative possibilities for hip conditions, the combined effect of these two have not received much evaluation. The purpose of this study is to evaluate the effect of physiotherapy in conjunction with a combined corticosteroid and hyaluronic acid intraarticular injection on patient outcomes when compared to a corticosteroid and hyaluronic acid intraarticular injection alone.

Conditions

Osteoarthritis; Femoroacetabular Impingement Syndrome; Labrum Injury of the Hip Joint

Keywords

Hip; Osteoarthritis; Femoroacetabular impingement; Labral tear; Hyaluronic acid; Corticosteroid; Physical Therapy; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  NPRS is scored by asking the patient to circle the number between 0 and 10 that fits best to their pain intensity. Zero represents "no pain" whereas the upper limit of 10 represents "worst possible pain". The patient score is determined as a score out of 10 based on where they indicate their pain falls by selecting a number between 0 and 10 which most accurately represents their pain.

  6 months post-injection

Secondary Outcomes (4)

• International Hip Outcome Tool 12 item (iHOT-12)

  6 months post-injection

• EuroQol-5D-5L (EQ-5D)

  6 months post-injection

• Medication Use

  6 months post-injection

• Adverse Events

  6 months post-injection

Study Arms (2)

Hyaluronic and corticosteroid injection with physical therapy

EXPERIMENTAL

Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint. Patients will also receive an 8-week physiotherapy protocol, consisting of 8 visits. The protocol will consist of 1 visit per week.

Drug: Hyaluronic and corticosteroid injection; Other: Physical Therapy

Hyaluronic and corticosteroid injection

ACTIVE COMPARATOR

Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint.

Drug: Hyaluronic and corticosteroid injection

Interventions

Hyaluronic and corticosteroid injection DRUG

Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint.

Hyaluronic and corticosteroid injection; Hyaluronic and corticosteroid injection with physical therapy

Physical Therapy OTHER

Patients will receive an 8-week physiotherapy protocol, consisting of 8 visits. The protocol will consist of 1 visit per week.

Hyaluronic and corticosteroid injection with physical therapy

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 40-60 years old.
• Patients with mild hip arthritis (Kellgren-Lawrence grade 2 or lower) with or without a labral tear and/or femoroacetabular impingement and/or mild hip dysplasia.
• Patients who demonstrate more than 50% reduction in hip pain following a diagnostic injection (ultrasound guided intra-articular anaesthetic only).
• Able to subsidize private physiotherapy services.
• Able to provide informed consent.

You may not qualify if:

• Active infection
• Osteonecrosis of the hip, moderate to severe arthritis (Kellgren-Lawrence grade 3 or higher), or moderate-to-severe hip dysplasia
• Previous hip fracture, pelvic fracture, or lower limb fracture,
• Previous surgery to the pelvis, hip or lower limb
• Hypermobility disorder or connective tissue disease (e.g. Ehler's-Danlos syndrome, Marfan's syndrome etc.)
• Patients with chronic low back pain and/or sciatica
• Patients who received an intra-articular steroid hip injection within 3 months
• Patients who have previously received a hyaluronic acid injection
• Injuries sustained in a motor vehicle collision.
• Injuries sustained in the workplace and have a worker's compensation claim.
• Injuries resulting in a medico-legal dispute.
• Patients who are pregnant of planning to become pregnant
• Currently enrolled in a study that does not permit co-enrollment
• Unable to obtain informed consent
• Unable to comply with the study protocol

Sponsors & Collaborators

• ArthroBiologix Inc.: lead

Study Sites (1)

ArthroBiologix

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Femoracetabular Impingement

Interventions

Adrenal Cortex Hormones; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Therapeutics; Rehabilitation

Central Study Contacts

Steven Phillips

CONTACT

(289) 389-8181; steve.phillips@myorthoevidence.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 23, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)