HIT Reverse Hip Replacement System for Osteoarthritis

Recruiting at 4 trial locations

Overseen By George Diamantoni

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Hip Innovation Technology

Disqualifiers: Renal insufficiency, Inflammatory DJD, Active infection, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new hip replacement device called the HIT Reverse Hip Replacement System. It aims to see if this new device is safe and effective for patients who need a total hip replacement. The device works by replacing damaged parts of the hip with artificial ones to improve movement and reduce pain.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the HIT Reverse Hip Replacement System treatment for osteoarthritis?

The effectiveness of hip replacement surgery, which is similar to the HIT Reverse Hip Replacement System, has been shown to improve pain and hip function in patients with conditions like necrosis of the femoral head. This suggests that similar improvements might be expected for osteoarthritis patients using the HIT system. ^{1 2 3 4 5}

What safety data exists for the HIT Reverse Hip Replacement System and similar hip systems?

The safety data for similar hip systems, such as those using metal-on-XLPE or ceramic-on-XLPE bearings, indicate some concerns. A study on a ceramic liner system showed a high rate of loosening, leading to revisions, and some patients experienced noise like squeaking or clicking. Another review found a low incidence of adverse reactions to metal debris in modular dual-mobility constructs, but there were concerns about metal ion levels and the need for proper implant seating to avoid complications. ^{6 7 8 9 10}

How is the HIT Reverse Hip Replacement System treatment different from other treatments for osteoarthritis?

The HIT Reverse Hip Replacement System is unique because it uses a reverse design with a femoral cup and acetabular ball, which enhances mechanical stability compared to traditional hip replacements. This novel design aims to reduce the common issue of instability after hip replacement surgery. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for individuals aged 50-75 needing a hip replacement due to conditions like osteoarthritis or avascular necrosis. Candidates must be able to attend follow-ups and have no excessive operative risks, allergies to titanium/XLPE, severe renal insufficiency, neuromuscular diseases, BMI over 40, active infections or certain cancers within the last 5 years.

Inclusion Criteria

Patient is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires

Patient has a signed and dated Informed Consent Form (ICF)

I am between 50 and 75 years old.

Exclusion Criteria

Patient has a Body Mass Index (BMI) of 40 or higher

I need both hips replaced or have a hip replacement planned for the other side within 2 years.

I had hip surgery on the opposite side over 2 years ago and still feel pain of at least 2 out of 10.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary total hip arthroplasty using either the HIT Reverse Hip Replacement System or a control hip system

Immediate post-surgery

1 visit (in-person)

Post-surgical care and rehabilitation

Standard of care post-surgical care and rehabilitation for both arms

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including metal ion levels and radiographic evaluations

10 years

Multiple visits at 1, 2, 3, 4, 5, 7, and 10 years

Treatment Details

Interventions

• Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination (Hip Replacement System)
• Hip Innovation Technology Reverse Hip Replacement System (Hip Replacement System)

Trial Overview The study tests the safety and effectiveness of the HIT Reverse Hip Replacement System compared to existing hip systems with metal-on-XLPE or ceramic-on-XLPE bearings in patients undergoing total hip replacement.

Participant Groups

Group I: Experimental Arm - HIT Reverse HRS Experimental Treatment 1 Intervention

Subjects in the Experimental Arm will receive the HIT Reverse HRS Investigational Device. Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.

Group II: Control Arm Active Control 1 Intervention

Subjects in the Control Arm will receive one of the already-marketed semi- constrained uncemented hip systems using a metal-on-highly-cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination.

Hip Innovation Technology Reverse Hip Replacement System is already approved in Canada for the following indications:

Approved in Canada as HIT Reverse HRS for:

• Total Hip Replacement

Who Is Running the Clinical Trial?

Hip Innovation Technology

Lead Sponsor

Trials

2

Recruited

390+

Findings from Research

In a study of 86 patients with necrosis of the femoral head, modified artificial hip replacement surgery showed a significantly higher treatment efficacy (93.02%) compared to conventional hip replacement (79.07%).

Patients who underwent the modified procedure experienced greater reductions in pain (VAS scores) and improvements in hip function (Harris hip scores) and motor function (Fugl-Meyer scores), while also having a lower incidence of adverse reactions (6.98% vs. 16.28%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of hip replacement surgery on clinical efficacy, VAS score and Harris hip score in patients with femoral head necrosis. Li, F., Zhu, L., Geng, Y., et al.[2021]

The Spanish version of the Hip Outcome Score (HOS) has been successfully translated and validated for use in patients undergoing hip arthroscopy, demonstrating high reliability with an intraclass correlation coefficient of 0.95 for activities of daily living (ADL) and 0.94 for sports.

This validated tool shows strong internal consistency and sensitivity to change, making it effective for assessing treatment outcomes in both Spanish- and English-speaking patients, thus facilitating cross-cultural research in hip pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Spanish version of the Hip Outcome Score: a multicenter study. Seijas, R., Sallent, A., Ruiz-Ibán, MA., et al.[2021]

A study involving 399 patients showed that the modified Harris hip score (MHHS) and Oxford hip score (OHS) are effective tools for evaluating functional outcomes after various types of hip surgeries, including primary total hip arthroplasty (THA) and hip hemiarthroplasty (HA).

There was a very strong correlation between the Harris hip score (HHS) and both MHHS and OHS across different patient groups, indicating that these scores can reliably assess hip function post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between Harris, modified Harris hip, and Oxford hip scores of patients who underwent hip arthroplasty and hemiarthroplasty following hip fracture. Kızkapan, TB., Mısır, A., Eken, G., et al.[2023]

The Brazilian version of the Hip Outcome Score (HOS-Brazil) was validated for use among 70 physically active patients with hip conditions, showing high reliability with Cronbach's alpha and ICC values greater than 0.9.

The HOS-Brazil demonstrated strong validity, with acceptable convergent and divergent validity scores, and no floor or ceiling effects, indicating it is a reliable tool for assessing hip function in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Brazilian version of the Hip Outcome Score (HOS) questionnaire. Costa, RMP., Cardinot, TM., Mathias, LNCDC., et al.[2019]

The Hip Outcome Score (HOS) demonstrated high reproducibility and responsiveness in a study of 157 patients with end-stage hip osteoarthritis, indicating it can effectively measure outcomes after total hip replacement surgery.

Despite its strengths, the HOS showed a significant amount of missing data and did not support a clear factor structure, suggesting it may not be suitable for routine clinical use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproducibility, validity, and responsiveness of the hip outcome score in patients with end-stage hip osteoarthritis. Naal, FD., Impellizzeri, FM., von Eisenhart-Rothe, R., et al.[2019]

Personalized total hip arthroplasty (THA) with a large diameter head (LDH) significantly improves outcomes by providing an impingement-free range of motion and reducing the risk of dislocation, which is crucial for achieving a pain-free joint similar to a natural hip.

The use of LDH THA not only restores normal gait parameters but also enhances patient satisfaction and allows for unrestricted activities, making it a preferred option for patients with a life expectancy of over 20 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Hip Joint Replacement with Large Diameter Head: Current Concepts. Vendittoli, PA., Martinov, S., Morcos, MW., et al.[2022]

In a study involving 181 hips, the new seleXys TH+ cup with a ceramic liner showed a 92% survival rate over two years, but 14 hips experienced radiological loosening, leading to a high failure rate that raised concerns about the implant's reliability.

Despite the use of large heads, there was no improvement in range of motion, and issues like squeaking and clicking were reported, prompting the decision to discontinue the use of this implant system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poor outcome of a spherical pressfit cup with a modern ceramic liner: a prospective cohort study of 181 cups. Ilchmann, T., Zwicky, L., Gersbach, S., et al.[2017]

The paper evaluates the Metha® short hip stem system, highlighting its potential benefits and uncertainties in indications, particularly for elderly and obese patients, as well as those with specific hip conditions like avascular necrosis and dysplasia.

There is a lack of statistically evaluated data guiding the use of short stem hip replacements, leading to varying recommendations from manufacturers, which underscores the need for further research to clarify appropriate indications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short Stem for Total Hip Arthroplasty (THA) - Overview, Patient Selection and Perspectives by Using the Metha® Hip Stem System. Ishaque, BA.[2022]

The use of modular dual-mobility (MDM) constructs in total hip replacement (THR) shows a low incidence of adverse reactions to metal debris (ARMD), with only 0.3% of cases requiring revision surgery, based on a systematic review of 16 articles involving 1312 cases.

Dislocation rates were also low at 0.8%, but there are concerns about wear on the metal liner and potential complications from improper seating of components, highlighting the need for careful surgical technique when using MDM prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reaction to metal debris due to fretting corrosion between the acetabular components of modular dual-mobility constructs in total hip replacement: a systematic review and meta-analysis. French, JMR., Bramley, P., Scattergood, S., et al.[2021]

Dual-mobility articulations are now available in North America for total hip arthroplasty and revision surgeries, providing a potential solution for addressing instability risks in complex cases.

Surgeons must carefully consider the unique advantages and disadvantages of dual-mobility designs, as well as the relevant surgical techniques and existing literature, before selecting this implant option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Dual-mobility Cups in Total Hip Arthroplasty. Konan, S., Duncan, CP., Garbuz, DS., et al.[2015]

The novel reverse total hip implant showed excellent fixation with minimal acetabular and femoral subsidence over 24 months, indicating a low risk of revision surgery in the long term.

Patient-reported outcomes significantly improved at the two-year follow-up, demonstrating the clinical safety and efficacy of this new hip replacement design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiostereometric analysis and clinical outcomes of a novel reverse total hip system at two years. Turgeon, TR., Hedden, DR., Bohm, ER., et al.[2023]

In a study of 31 patients undergoing total hip arthroplasty, those with large-diameter femoral heads (average size 45 mm) showed significantly better walking speed at 1 and 3 months post-surgery compared to those with conventional 28-mm heads.

While both groups improved in hip function and gait parameters over time, the large-diameter head group had lower stride length and swing power differences at 1 month, indicating a more effective early restoration of gait.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of the femoral head size on early postoperative gait restoration after total hip arthroplasty. Zhou, YX., Guo, SJ., Liu, Q., et al.[2009]

The cementless Variall hip system demonstrated excellent clinical outcomes with an average Harris Hip Score of 94.3 points after an average follow-up of 42 months in 100 patients, indicating high patient satisfaction and functional improvement.

Radiographic evaluations showed no migration of the implant or radiolucencies, confirming the stability of the implant and suggesting a strong bond between the prosthesis and bone, which is crucial for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tribological considerations for a new hip system. Knahr, K., Karamat, L., Loho, G., et al.[2016]

In a study of 9 patients who underwent total hip replacement (THR) for secondary osteoarthritis due to Perthes disease, the average Harris hip score improved from 34 preoperatively to 93 after an average follow-up of 15 years, indicating significant improvement in hip function.

All patients reported decreased pain and improved function, with no radiographic evidence of component loosening, suggesting that THR is a safe and effective long-term treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Total hip replacement after Legg-Calvé-Perthes disease]. Pietrzak, K., Strzyzewski, W., Pucher, A., et al.[2016]

In a study of 24 patients undergoing total hip replacement with a ceramic-on-ceramic system, significant improvements were observed in hip function, as measured by the Harris Hip Score (HHS), WOMAC, and Numeric Rating Scale (NRS), with no postoperative complications reported.

The use of a cementless hip implant with a ceramic insert showed no signs of loosening or migration, indicating a promising long-term stability and effectiveness for treating hip osteoarthritis in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of bearings with integrated ceramic insert in cementless total hip arthroplasty – a preliminary report. Kotela, I., Lorkowski, J., Sikorski, W., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of hip replacement surgery on clinical efficacy, VAS score and Harris hip score in patients with femoral head necrosis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Validation of the Spanish version of the Hip Outcome Score: a multicenter study. [2021]

3. Turkey pubmed.ncbi.nlm.nih.gov

Correlation between Harris, modified Harris hip, and Oxford hip scores of patients who underwent hip arthroplasty and hemiarthroplasty following hip fracture. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Validation of the Brazilian version of the Hip Outcome Score (HOS) questionnaire. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Reproducibility, validity, and responsiveness of the hip outcome score in patients with end-stage hip osteoarthritis. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Hip Joint Replacement with Large Diameter Head: Current Concepts. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Poor outcome of a spherical pressfit cup with a modern ceramic liner: a prospective cohort study of 181 cups. [2017]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Short Stem for Total Hip Arthroplasty (THA) - Overview, Patient Selection and Perspectives by Using the Metha® Hip Stem System. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse reaction to metal debris due to fretting corrosion between the acetabular components of modular dual-mobility constructs in total hip replacement: a systematic review and meta-analysis. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The Role of Dual-mobility Cups in Total Hip Arthroplasty. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Radiostereometric analysis and clinical outcomes of a novel reverse total hip system at two years. [2023]

12. China pubmed.ncbi.nlm.nih.gov

Influence of the femoral head size on early postoperative gait restoration after total hip arthroplasty. [2009]

13. Czech Republic pubmed.ncbi.nlm.nih.gov

Tribological considerations for a new hip system. [2016]

14. Poland pubmed.ncbi.nlm.nih.gov

[Total hip replacement after Legg-Calvé-Perthes disease]. [2016]

15. United States pubmed.ncbi.nlm.nih.gov

Use of bearings with integrated ceramic insert in cementless total hip arthroplasty – a preliminary report. [2019]