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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Femoroacetabular Impingement Syndrome; Labrum Injury of the Hip Joint
• Intervention / Treatment: Drug: Hyaluronic and corticosteroid injection; Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Phillips; Phone Number: (289) 389-8181; Email: steve.phillips@myorthoevidence.com

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • ArthroBiologix
      • Contact: Steven Phillips; Phone Number: (289) 389-8181; Email: steve.phillips@myorthoevidence.com
      • Principal Investigator: Olufemi Ayeni, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged 40-60 years old.
2. 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.
3. Patients who demonstrate more than 50% reduction in hip pain following a diagnostic injection (ultrasound guided intra-articular anaesthetic only).
4. Able to subsidize private physiotherapy services.
5. Able to provide informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic and corticosteroid injection with physical therapy; 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; Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint.; Other: Physical Therapy; Patients will receive an 8-week physiotherapy protocol, consisting of 8 visits. The protocol will consist of 1 visit per week.
Active Comparator: Hyaluronic and corticosteroid injection; 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; Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Hip Outcome Tool 12 item (iHOT-12)	The tool consists of 12 VAS questions evaluating 4 areas: symptoms and functional limitations, sports and recreational activities, job-related concerns, and social, emotional, and lifestyle concerns. The patient score is determined by averaging the score of the 12 items in the iHOT-12 and is presented on a scale of 0-100, with 0 representing the worst possible function and 100 representing the best possible function.	6 months post-injection
EuroQol-5D-5L (EQ-5D)	A quality-of-life measurement instrument that provides a score based on 5 dimensions of quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This brief questionnaire is self-reported by the patient and determines a quality of life score between 0 and 1, where 1 represents perfect health and 0 represents death.	6 months post-injection
Medication Use	Patient medication use, including types (analgesics, NSAIDs, opioids) will be asked at baseline. Patient will then be asked at 3- and 6- months if they are currently using pain medication, and if so whether their use has decreased, stayed the same, or increased.	6 months post-injection
Adverse Events	Adverse events experienced over the course of the study will be documented.	6 months post-injection

Collaborators and Investigators

• Sponsor: ArthroBiologix Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 27, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Osteoarthritis; Physical Therapy; Physiotherapy; Corticosteroid; Hyaluronic acid; Hip; Femoroacetabular impingement; Labral tear
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Femoracetabular Impingement; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Therapeutics; Rehabilitation; Physical Therapy Modalities; Adrenal Cortex Hormones
• Other Study ID Numbers: nonophip

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes