New hip implant put to the test in arthritis patients
NCT ID NCT02836262
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are studying a new hip replacement device called the HIT Hip Replacement System in people aged 65 to 79 with hip arthritis. The trial measures how well the device improves pain and function over two years using patient questionnaires and X-rays. It also tracks safety by recording any problems related to the device.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HIT Hip Replacement System, a hip replacement device
- What this could lead to
- If it works, this could offer another hip replacement option that improves pain and function for people with hip arthritis.
- What could go wrong
- The device may not outperform existing hip replacements, and any new implant carries risks of loosening, infection, or revision surgery. The study is small and limited to older adults.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2017
- Expected to finish
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Sep 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary total hip replacement. * Age between 65 and 79 years (inclusive) at the time of enrollment. * Patient is a suitable candidate for primary total hip replacement at the discretion of the Investigator. * Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on a scale from 0 (best) to 96 (worst) * Signed and dated informed consent document. * Patient is willing and able to participate in required follow-up visits at the Investigational site and to complete study procedures and questionnaires. Exclusion Criteria: * Patient has had total hip replacement, hemi-arthroplasty, or fusion in either hip in the last 12 months; * Patient has planned total hip arthroplasty on a contra-lateral joint in the next 12 months; * Patient has a known allergy to any component of the study device; * Patient has a history of active sepsis in the joint; * Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible; * Patient has total or partial absence of the muscular or ligamentous apparatus; * Patient has known moderate to severe renal insufficiency; * Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in either leg (based on the Investigator's discretion); * Patient has a deformity of the affected limb or significant anatomic variance of the affected hip; * Patient has an active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study; * Patient has any condition which may, in the opinion of the Investigator, interfere with the total hip replacement survival or patient outcomes (e.g. Paget's disease, Charcot's disease); * Patient has rheumatoid arthritis or other autoimmune condition that affect joints (e.g. Lupus Arthritis); * Patient has any condition that would interfere with patient self-assessment or pain, the function or quality of life required for patient reported outcomes during the study (based on the Investigator's discretion); * Body Mass Index (BMI) of 40 or more; * Patient has an active infection (e.g. hepatitis, AIDS, ARC) - systemic or at the site of intended surgery; * Patient is currently participating in any investigational study not related to this study's pre-operative or post-operative care; * Patient has any other severe acute or chronic medical condition that may interfere with the interpretation of the study results, in the judgment of the Investigator, which would make the patient inappropriate for entry into this study; * Patient has a history of metabolic bone disease (e.g. Paget's disease or osteomalacia); * Patient is currently pregnant or is planning to become pregnant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Orthopaedic Innovation Centre
RECRUITINGWinnipeg, Manitoba, R2K 2M9, Canada
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