Hip Replacement System for Hip Osteoarthritis

((HRS-P) Trial)

Overseen By Thomas Turgeon, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Hip Innovation Technology

Disqualifiers: Rheumatoid arthritis, Renal insufficiency, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator to understand any specific requirements.

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

Research shows that hip replacement surgery, similar to the HIT Hip Replacement System, improves pain and hip function in patients with conditions like femoral head necrosis and ankylosed hip, suggesting potential benefits for hip osteoarthritis as well. ^{1 2 3 4 5}

Is the HIT Hip Replacement System safe for humans?

The Birmingham Hip Resurfacing system, a similar hip treatment, has been associated with some safety concerns, such as adverse reactions to metal debris and certain types of fractures. However, it is generally used as an alternative to traditional hip replacement, especially in younger patients. ^{6 7 8 9 10}

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

The HIT Hip Replacement System is unique because it uses a ceramic-on-ceramic system, which reduces complications like polyethylene wear and metalosis (metal debris in the body), making it particularly beneficial for younger patients who need long-lasting implants. ^{11 12 13 14 15}

What is the purpose of 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.

Research Team

Thomas Turgeon, MD

Principal Investigator

Orthopaedic Innovation Centre

Branko Kopjar, MD, PhD

Principal Investigator

Nor Consult, LLC

Eligibility Criteria

This trial is for individuals aged 65-79 with non-inflammatory degenerative joint diseases like osteoarthritis, needing a hip replacement. They must have a certain level of pre-surgery pain and disability, be able to follow the study's procedures, and not have conditions that could affect their participation or assessment such as autoimmune joint diseases, severe bone deficiencies, or recent other hip surgeries.

Inclusion Criteria

I need a hip replacement due to a non-inflammatory joint condition like osteoarthritis.

My pre-surgery pain and joint function score is 40 or higher.

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

Body Mass Index (BMI) of 40 or more.

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.

My hip bones are too weak for implants to attach properly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo total hip arthroplasty using the HIT Hip Replacement System

1 day

1 visit (in-person)

Post-operative Recovery

Participants recover from surgery and initial safety and effectiveness are evaluated

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person)

Treatment Details

Interventions

• HIT Hip Replacement System

Trial Overview The HIT Hip Replacement System is being tested in patients undergoing total hip arthroplasty. The study aims to assess how effective and safe this system is by looking at patient feedback, clinical outcomes, X-rays results, and any unexpected events related to the device.

Participant Groups

Group I: HIT Hip Replacement System (HRS) Experimental Treatment 1 Intervention

Single group assignment with historical controls.

HIT Hip Replacement System is already approved in United States, European Union for the following indications:

Approved in United States as HIT Reverse Hip Replacement System for:

• End-stage, symptomatic hip osteoarthritis
• Hip osteonecrosis
• Congenital hip disorders including hip dysplasia
• Inflammatory arthritic conditions

Approved in European Union as HIT Reverse Hip Replacement System for:

• End-stage, symptomatic hip osteoarthritis
• Hip osteonecrosis
• Congenital hip disorders including hip dysplasia
• Inflammatory arthritic conditions

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]

Total hip arthroplasty significantly improves hip function in patients with ankylosed hips, as shown by an increase in the Harris Hip Score from an average of 48.53 before surgery to 88.22 after 12 months (P<0.001).

The study highlights the importance of monitoring for complications, as some patients experienced issues post-surgery, which could affect overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of total hip arthroplasty in patients with ankylosed hip. Siavashi, B., Mohseni, N., Zehtab, MJ., 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 Oxford Hip Score (OHS) does not show a ceiling or floor effect in measuring outcomes for hip replacement surgery, based on a large analysis of 93,253 patients, indicating its validity as a patient-reported outcome measure.

Postoperatively, 11.6% of patients achieved the best score on the OHS, with younger patients (ages 50-59) showing the highest improvement, suggesting that while the OHS is effective overall, there may be limitations in its subscales for specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Floor and ceiling effects in the OHS: an analysis of the NHS PROMs data set. Lim, CR., Harris, K., Dawson, J., et al.[2022]

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]

In a study of 32 patients who received the Birmingham Hip Resurfacing (BHR) device, 17 out of 42 hips showed definite or probable adverse reactions to metal debris (ARMD), indicating a concerning prevalence of this complication.

The study suggests that systematic follow-up using metal ion measurements and imaging is necessary for patients with BHR implants, as factors like gender and head size were not linked to ARMD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reaction to metal debris after Birmingham hip resurfacing arthroplasty. Junnila, M., Seppänen, M., Mokka, J., et al.[2019]

A meta-analysis of 11 studies involving 659 patients found that 91.8% of individuals were able to return to sport (RTS) by three months post-hip resurfacing arthroplasty (HRA), indicating a quick recovery for most patients.

By six months post-surgery, this percentage increased to 96.8%, and overall, 90.9% of patients were able to RTS by the three-year follow-up, suggesting that HRA generally allows for a successful return to pre-disease activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis assessing time for return to sport following hip resurfacing. Magan, A., Wignadasan, W., Kayani, B., et al.[2023]

Birmingham hip resurfacing (BHR) shows excellent midterm survival rates of 95.1% in females and 99.0% in males after an average follow-up of about 71 months, indicating its efficacy as an alternative to total hip replacement in younger patients.

The study identified female gender and smaller head sizes as significant risk factors for aseptic failure and complications, suggesting that these factors may influence the suitability of BHR for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Birmingham Hip Resurfacing in Patients 55 Years or Younger: Risk Factors for Poor Midterm Outcomes. Halawi, MJ., Brigati, D., Messner, W., et al.[2022]

In a long-term study of 82 patients (99 hips) who underwent hip resurfacing arthroplasty (HRA) for osteonecrosis, the 15-year survivorship rate was 90.3%, indicating that HRA is a durable option for this condition.

Patients reported good clinical outcomes, with high scores for pain and function, and no wear-related failures were observed, suggesting that HRA is a safe and effective treatment for advanced osteonecrosis of the femoral head.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip resurfacing for osteonecrosis: two- to 18-year results of the Conserve Plus design and technique. Amstutz, HC., Le Duff, MJ.[2017]

The Birmingham hip system is a widely used design for hip resurfacing, but it can be associated with specific types of fractures, primarily subcapital fractures.

This report highlights a rare case of an intertrochanteric fracture following the procedure, which was successfully treated with a reversed distal femoral locking plate, leading to excellent clinical and radiological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal fixation of an intertrochanteric femoral fracture after Birmingham hip resurfacing arthroplasty. Carpentier, K., Govaers, K.[2012]

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]

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]

A survey of 170 UK physiotherapists and occupational therapists revealed that 97% routinely prescribe hip precautions and commonly provide equipment like raised toilet seats and grabbers to patients after total hip replacement (THR).

There is significant variability in the advice regarding the duration of hip precautions and equipment use, indicating a need for more tailored approaches rather than a one-size-fits-all strategy in post-THR care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

UK survey of occupational therapist's and physiotherapist's experiences and attitudes towards hip replacement precautions and equipment. Smith, TO., Sackley, CM.[2019]

Total hip replacement is highly successful, with implant fixation achieved through cemented, cementless, or hybrid methods, all aiming for long-term stability and function.

Wear of polyethylene components in hip implants can lead to inflammation and loosening, prompting the development of more wear-resistant materials and minimally invasive techniques to enhance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of hip osteoarthritis: update in total hip arthroplasty]. Ilizaliturri Sánchez, VM., Mangino Pariente, G., Camacho Galindo, J.[2012]

Total hip arthroplasty has been a successful surgical procedure since the 1960s, providing significant pain relief and improved function for patients suffering from hip arthritis (coxa arthrosis).

As the procedure has evolved over nearly 40 years, new challenges have emerged, prompting ongoing discussions about potential solutions to enhance its long-term effectiveness and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in total hip arthroplasty. Tate, D., Sculco, TP.[2010]

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. Iran pubmed.ncbi.nlm.nih.gov

Clinical outcomes of total hip arthroplasty in patients with ankylosed hip. [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

Floor and ceiling effects in the OHS: an analysis of the NHS PROMs data set. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Sweden pubmed.ncbi.nlm.nih.gov

Adverse reaction to metal debris after Birmingham hip resurfacing arthroplasty. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

A meta-analysis assessing time for return to sport following hip resurfacing. [2023]

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

Birmingham Hip Resurfacing in Patients 55 Years or Younger: Risk Factors for Poor Midterm Outcomes. [2022]

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

Hip resurfacing for osteonecrosis: two- to 18-year results of the Conserve Plus design and technique. [2017]

10. Belgium pubmed.ncbi.nlm.nih.gov

Internal fixation of an intertrochanteric femoral fracture after Birmingham hip resurfacing arthroplasty. [2012]

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

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

12. Poland pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

UK survey of occupational therapist's and physiotherapist's experiences and attitudes towards hip replacement precautions and equipment. [2019]

14. Spain pubmed.ncbi.nlm.nih.gov

[Surgical treatment of hip osteoarthritis: update in total hip arthroplasty]. [2012]

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

Advances in total hip arthroplasty. [2010]