CLINICAL TRIAL

Treatment for Osteoarthritis, Hip

Waitlist Available · 18+ · All Sexes · Boston, MA

This study is evaluating whether labral repair is beneficial for patients with hip pain.

See full description

About the trial for Osteoarthritis, Hip

Eligible Conditions
Osteoarthritis, Hip · Acetabular Labrum Tear · Hip Arthroscopy · Femoracetabular Impingement · Femoro-acetabular Impingement (FAI) · Physical Therapy · Osteoarthritis

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)
PROCEDURE
Control Group 2
Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group)
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Conditions that are not treatable by either arthroscopy or physical therapy include septic arthritis, osteonecrosis, hemarthrosis, iliotibial band syndrome, fractures of the femoral neck or head, fractures of the acetabulum, greater trochanteric pain syndrome, sacroiliac joint pain, and piriformis syndrome show original
on MRI MRI documentation of a tear in the acetabular labrum suggests that a patient has a labral tear show original
The study participants must be willing to undergo randomization and be able to understand and sign the informed consent document show original
The availability of hip radiographs and MRI scans is needed in order to assess a person's eligibility for hip replacements. show original
People between the ages of 40 and 49 are more likely to have undetectable OA on imaging, while those 50 years or older are more likely to have detectable OA. show original
The following symptoms may suggest a tear in the acetabular labrum: catching, clicking, popping, pain when sitting, episodic pain, pain when hip flexing, adducting, and/or internally rotating show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 months, 6 months, 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months, 6 months, 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 months, 6 months, 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Osteoarthritis, Hip. Measurement will happen over the course of 3 months, 6 months, 12 months.

Change in mHHS Surveys From Preoperative to Various Postoperative Timepoints
3 MONTHS, 6 MONTHS, 12 MONTHS
Full Name of Outcome: modified Harris Hip Score (mHHS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of mHHS: Min: 0 Max: 100 Higher score indicates better hip functionally. No subscores or subscales. The mean changes in scores required to achieve a minimically clinically important difference is 6.9.
3 MONTHS, 6 MONTHS, 12 MONTHS
Degree of Improvement on Hip VAS Pain Score
3 MONTHS, 6 MONTHS, 12 MONTHS
At routine follow-up visits patients will be asked to rate hip pain using the VAS (Visual Analog Scale) Score Min: 0--no pain Max: 10--worst pain experienced in their life Increments of 1. Categories: 1--3: mild pain 4--6: moderate pain 7--10: severe pain There is no reduction in VAS score that is considered a minimally clinically important difference.
3 MONTHS, 6 MONTHS, 12 MONTHS
Change NAHS Surveys From Preoperative to Various Postoperative Timepoints
3 MONTHS, 6 MONTHS, 12 MONTHS
Full Name of Outcome: Non-Arthritic Hip Score (NAHS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery: Scale of NAHS: Min: 0 Max: 100 No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. No subscores or subscales. No specific score to indicate a minimally clinically important difference.
3 MONTHS, 6 MONTHS, 12 MONTHS
Change HOS Surveys From Preoperative to Various Postoperative Timepoints
3 MONTHS, 6 MONTHS, 12 MONTHS
Full Name of Outcome: HOS--Hip Outcome Score. Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of HOS: Min: 0 Max: 100 No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. The mean change in HOS score required to achieve a minimally clinically important difference is 8.8.
3 MONTHS, 6 MONTHS, 12 MONTHS
Change iHOT--33 Surveys From Preoperative to Various Postoperative Timepoints
3 MONTHS, 6 MONTHS, 12 MONTHS
Full Name of Outcome: International Hip Outcome Tool--33 Questions Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of iHOT-33: Min: 0 Max: 100 No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. No subscores or subscales The mean changes in iHOT-33 scores required to achieve minimally clinically important difference is 15.1.
3 MONTHS, 6 MONTHS, 12 MONTHS
Change LEFS Surveys From Preoperative to Various Postoperative Timepoints
3 MONTHS, 6 MONTHS, 12 MONTHS
Full Name of Outcome: Lower Extremity Functional Scale (LEFS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of LEFS: Min: 0 Max: 100 No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. There is no designated improvement that is deemed to be a minimally clinically important difference
3 MONTHS, 6 MONTHS, 12 MONTHS

Who is running the study

Principal Investigator
S. D. M.
Scott D Martin, Principal Investigator, Director, Joint Preservation Service, Director, MGH Sports Medicine Fellowship
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is osteoarthritis, hip?

Hip [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) is a common condition of the hip and knee joints that can affect the function and life of an individual. In addition to pain (either chronic or acute) and stiffness, hip osteoarthritis has detrimental effects on the ability to work and enjoy one's life. More than 70% of women and one third of men will develop OA between the ages of 45-64 years. Hip OA can be diagnosed because of the following signs or symptoms: pain or stiffness in one's hip joints, loss of flexibility in the hips, loss of full use of the hips, and a visible defect in the cartilage of one or both hips.

Anonymous Patient Answer

What causes osteoarthritis, hip?

Hip osteoarthritis is more likely to have a genetic or hormonal origin. The increased cartilage breakdown rate is caused by increased osteoclast number and consequent cartilage matrix breakdown. This is caused by increased interleukin (IL)-1-alpha, IL-4 and tumour necrosis factor-alpha (TNF-alpha).

Anonymous Patient Answer

What are the signs of osteoarthritis, hip?

All aspects of clinical examination are useful in the diagnosis of OA. The use of specific clinical and radiological characteristics is also very important to help in the diagnosis of OA. Subjective assessment in terms of pain levels can aid in discriminating between mild and severe OA. Clinical evaluation can also help in determining the optimal timing for therapeutic intervention.

Anonymous Patient Answer

Can osteoarthritis, hip be cured?

The outcomes after total joint replacement, in terms of pain and function, are worse after primary THJR than after revision THJR, suggesting that the natural history of OA, hip is that the outcome is not improved by revision THJR, at least with respect to pain relief.

Anonymous Patient Answer

How many people get osteoarthritis, hip a year in the United States?

At least 150,000 people may have OA and/or hip replacement a year in the U.S. The prevalence of OA (10-24% of people) and/or hip replacement (19-33.5%) are increasing annually in this population.

Anonymous Patient Answer

What are common treatments for osteoarthritis, hip?

The use of various nonsteroidal anti-inflammatory drugs (NSAIDs) and non-opioid analgesics is the most common treatment for osteoarthritis. Some surgeons are more reluctant to prescribe NSAIDs, especially in younger postmenopausal women because of an increased rate of side effects and a lack of proven benefit of treatment. The pain treatment non-opioid analgesics do not affect the pain, but may result in adverse effects with long-term use. Physical therapy and medication-related benefits of analgesics can be realized. Surgical procedures, such as hip resurfacing surgery, have not been proven to relieve pain. Additionally, surgical implants and joint prostheses may be employed when pain control is inadequate.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

Although there are a few clinical trials on osteoarthritis available, some of them have been approved by the US Food and Drug Administration, which means that they were designed and carried out before the approval of the drug. Clinical trials on osteoarthritis can be found at [Registro Clinical Trials on Osteoarthritis (RCTOA) (https://www.rctoa.org/)] in the US and at [PubMed Clinical trials (https://www.ncbi.nlm.nih.gov/pubmed)] in the UK.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

Use of [placebos] for placebo-controlled studies can limit the statistical power of the study by wasting a small amount of statistical power on placebo response(s). As a guideline we recommend to set the statistical power of an individual trial as part of the design of the trial so that the risk of the study design being underpowered or overpowered can be evaluated by the statistical analyst. Whenever a clinical study is designed we should always keep in mind the expected risk of being underpowered or overpowered (how weak or how strong the drug is compared with placebo).

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

Treatment commonly used in this study in conjunction with other treatments was as commonly used as the treatment used by itself. Data from a recent study suggest that patients who require only one treatment can be carefully managed to avoid unnecessary use of treatments.

Anonymous Patient Answer

Have there been any new discoveries for treating osteoarthritis, hip?

Few trials are being performed for osteoarthritis. There is a lack of evidence-based treatment regimens for osteoarthritis. Clinicians are relying on the evidence from randomised trials to decide when best to treat osteoarthritis patients. In view of the lack of evidence, and the lack of evidence-based guidelines, the treatment needs revision and development to be better suited to the treatment of osteoarthritis of the hip.

Anonymous Patient Answer

What are the common side effects of treatment?

In summary, the side effects of treatment appear to be mild in the study participants. For example, people in the CEA group experienced nausea in 6%, the CAPE group experienced nausea in 4%, and the PORT group experienced nausea in 6%.

Anonymous Patient Answer

What is the latest research for osteoarthritis, hip?

The research from 2017 shows the potential to slow the progression of cartilage loss and knee OA, but not the condition itself. A new approach to knee pain could be a future therapy as well, but more research is needed.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Osteoarthritis, Hip by sharing your contact details with the study coordinator.