Home/Loved One/NCT02836262
NARECRUITING
View on ClinicalTrials.gov

Testing HIT Hip Replacement System for osteoarthritis of hip

Official title: Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty

A Multi-Center Prospective Study of the Hip Innovation Technology (HIT) Hip Replacement System in Primary Total Hip Arthroplasty

Condition: Osteoarthritis of HipSponsor: Hip Innovation TechnologyTarget enrollment: 100

Interventions

DEVICE

HIT Hip Replacement System

HIT Hip Replacement System

Canadian Sites (1)

Orthopaedic Innovation Centre

Winnipeg, Manitoba, Canada

RECRUITING

Eligibility Criteria

See who this study is looking for25 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Age between 65 and 79 years (inclusive) at the time of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
  • +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.
  • +Patient is a suitable candidate for primary total hip replacement at the discretion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
  • +Signed and dated informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → document.
  • +Patient is willing and able to participate in required follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → visits at the Investigational siteTrial siteA hospital or clinic where a study is actually run.Read more → and to complete study procedures and questionnaires.
  • +Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on a scale from 0 (best) to 96 (worst)

Exclusion

  • Patient has a known allergy to any component of the study device;
  • 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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s discretion);
  • 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 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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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);
  • Body Mass Index (BMI) of 40 or more;
  • 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.
  • Patient has an active infection (e.g. hepatitis, AIDS, ARC) - systemic or at the siteTrial siteA hospital or clinic where a study is actually run.Read more → of intended surgery;
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

What is being given or done in this study: HIT Hip Replacement System.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
  • armsInterventionsModule.interventions[].name
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

There is one group in this study.

From the trial registry

Built from this field:

  • armsInterventionsModule.armGroups[].type
Who the study is looking for

The study lists an age range of 65 years to 79 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 100 people.

The study is currently expected to finish around August 2026.

The main measurement is taken over: between pre-operative and 730 days (24 months).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) v3.0 Likert Scale Functional Limitations Score between baselineBaselineYour starting measurements, taken before treatment begins.Read more → (pre-operative) and the 730- day post-operative follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → time point — measured over between pre-operative and 730 days (24 months).

Change in Harris Hip Score between baseline (pre-operative) and the 730-day post-operative follow-up time point — measured over between pre-operative and 730 days (24 months).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT02836262 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About HIT Hip Replacement SystemDevice

HIT Hip Replacement System

From the trial registry — its own words, unedited.

What a device is here: A physical instrument, implant, app or piece of equipment being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 65 years to 79 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 65 years to 79 years.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: between pre-operative and 730 days (24 months).

The study as a whole is currently expected to finish around 2026-08-25.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 100 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Winnipeg, Manitoba, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

To evaluate effectiveness and safety of HHRS in subjects undergoing total hip arthroplasty (THA). Effectiveness will be evaluated using patient-reported, clinical, radiologic, and radiostereometric outcomes. Safety will be evaluated through the collection of device-related and unanticipated device-related adverse events.

Worth passing on?

Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.

Review the Care Package

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.