Bone Health Referral for Joint Replacement Surgery

Overseen By Savyasachi C Thakkar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Prior osteoporosis diagnosis, treatment

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

Compensation: Varies

Number of Visits: 3

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to improving bone health care for individuals undergoing hip or knee replacement surgery. Researchers aim to determine if direct referrals from surgeons to bone specialists before surgery can reduce complications, such as fractures. The study compares this new referral process, known as the Surgeon-Initiated Bone Health Referral Pathway, with the usual method, where primary doctors advise patients. Individuals with a DEXA scan-confirmed diagnosis of osteoporosis who have not received prior treatment may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative strategies in bone health care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the surgeon-driven bone health referral pathway is safe?

Research has shown that the Surgeon-Initiated Bone Health Referral Pathway aims to improve bone health in patients undergoing joint replacement surgery. In this approach, surgeons refer patients to bone specialists for a pre-surgery bone health check. While specific data on the safety of this pathway is not available, it is important to note that it does not involve any medications. Instead, it focuses on monitoring and managing bone health through additional lab tests and consultations.

As a new referral process rather than a medication or surgery, the risks are likely low. The process primarily involves more detailed checks and planning before surgery, which could help reduce complications. Patients should always consult their healthcare provider for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Surgeon-Initiated Bone Health Referral Pathway because it aims to address bone health proactively before joint replacement surgery. Unlike the standard approach, where patients are simply advised to discuss their bone health with a primary care provider, this new pathway involves a formal referral to an endocrinologist. This allows for a thorough evaluation, including additional bone health labs, and tailored treatment plans with medications, if needed. The goal is to optimize patients' bone health before surgery, potentially leading to better surgical outcomes and reducing complications associated with osteoporosis.

What evidence suggests that the Surgeon-Initiated Bone Health Referral Pathway is effective for reducing implant-related complications and fragility fractures?

Research has shown that a surgeon-led process for checking bone health, such as the Surgeon-Initiated Bone Health Referral Pathway studied in this trial, can improve outcomes for patients undergoing joint replacement surgery. Studies indicate that more than half of those receiving hip or knee replacements are at high risk for osteoporosis, a condition that weakens bones. Involving an endocrinologist, a hormone specialist, helps ensure a thorough bone health assessment before surgery. This approach has been linked to fewer implant-related problems and bone fractures. Educating patients about bone health and ensuring they receive appropriate treatment can lead to better recovery and fewer post-surgery issues. ^{1 2 5 6 7}

Who Is on the Research Team?

Savyasachi Thakkar, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals over 50 who have been diagnosed with osteoporosis through a DEXA scan and are undergoing lower extremity arthroplasty. It's not open to those who have already been diagnosed or treated for osteoporosis before.

Inclusion Criteria

I have been diagnosed with osteoporosis through a DEXA scan.

Exclusion Criteria

I have been treated for osteoporosis before.

I have been diagnosed with osteoporosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Patients undergo preoperative assessment including DEXA scan and additional bone health labs for those in the endocrinology referral pathway

4-6 weeks

1 visit (in-person), 1 visit (virtual for endocrinology consultation)

Surgery and Initial Postoperative Care

Patients undergo lower extremity arthroplasty and initial postoperative care

6-8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for implant-related complications and fragility fractures

2 years

Regular postoperative visits with the surgeon

What Are the Treatments Tested in This Trial?

Interventions

• Surgeon-Initiated Bone Health Referral Pathway

Trial Overview The study is testing if a bone health referral pathway initiated by surgeons can reduce complications and fragility fractures after joint replacement surgery, compared to the usual referrals made by primary care providers.

How Is the Trial Designed?

Group I: Surgeon-Initiated Bone Health Referral Pathway Experimental Treatment 1 Intervention

Patients assigned in the endocrinology bone health referral pathway would be formally referred by the surgeon to see endocrinology for clearance before undergoing lower extremity arthroplasty. In addition to normal labs, the surgeon will initiate additional bone health labs in these patients before consultation with endocrinology. Endocrinology providers will be available for a virtual consultation to review the patients DEXA and bone health labs; start the patient on the appropriate medication; and provide patient education regarding osteoporosis and bone health. For those undergoing evaluation by endocrinology, these providers will let the surgical team know when and whether the patient has initiated treatment.

Group II: Standard of Care Active Control 1 Intervention

The control arm will be composed of patients identified in the osteoporotic range like the endocrinology bone health referral pathway. These patients will be told by the surgeon that the patient has osteoporosis based on the DEXA scan and will be told to follow-up these results with the patient's primary care provider. These patients do not need bone health clearance before undergoing surgery. Only serum 25-hydroxyvitamin D levels will be added on to the patient's standard of care pre-operative labs. The control arm is the current standard of care. Comparing this pathway to the endocrinology referral pathway permits an assessment on the efficacy of the new pathway.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A survey of 409 trauma departments in Germany revealed that only 35% have a standardized clinical pathway for diagnosing and treating fragility fractures, indicating a significant gap in consistent care.

Among those following clinical pathways, only 30% adhered to national guidelines for diagnosis and 51% for therapy, highlighting an opportunity for improvement in osteoporosis management through better education and collaboration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reality of treatment of osteoporotic fractures in German trauma departments. A contribution for outcome research]. Vogel, T., Kampmann, P., Bürklein, D., et al.[2019]

The study found that the typical patient pathway for total hip replacement (THR) and total knee replacement (TKR) surgery in South Australia involves a lengthy waiting period of 2 to 3 years, divided into two phases: 9-24 months from referral to the initial appointment, and 12-15 months from the initial appointment to surgery.

Current Australian health policy overlooks the first phase of this pathway, which may lead to misunderstandings about patient experiences and could result in ineffective health reforms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The journey to total hip or knee replacement. Walters, JL., Mackintosh, S., Sheppard, L.[2014]

The Alberta Hip and Knee Replacement Project successfully implemented a new clinical pathway (NCP) for total hip and knee replacements, evaluated through a pragmatic randomized controlled trial involving 3,434 patients, which showed the feasibility of this approach in real clinical settings.

The study demonstrated that the NCP could be effectively compared to standard care, providing a model for health technology assessment that focuses on improving patient outcomes across various dimensions of care, including safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Alberta Hip and Knee Replacement Project: a model for health technology assessment based on comparative effectiveness of clinical pathways. Gooch, KL., Smith, D., Wasylak, T., et al.[2009]

Optimizing metabolic bone health before elective surgery is crucial for improving fracture healing and overall patient outcomes, highlighting the need for proactive evaluation and treatment of bone health issues.

A proposed model is suggested to help identify and treat patients at risk for bone metabolic problems, addressing the challenge of limited time and expertise among orthopedic surgeons in managing these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Outcomes By Optimizing Bone Health. Adams, JE., Fitton, L., Chen, AF., et al.[2022]

Joint arthroplasty clinical pathways include key interventions such as pre-admission education, rehabilitation, and postoperative care, which aim to improve the quality and efficiency of patient care.

While these pathways can enhance process and financial outcomes, the effects on clinical outcomes are mixed, indicating a need for further research on team and service outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key interventions and outcomes in joint arthroplasty clinical pathways: a systematic review. Van Herck, P., Vanhaecht, K., Deneckere, S., et al.[2019]

The implementation of a clinical pathway for hip fracture treatment at the Hospital for Joint Diseases has led to significant improvements in patient outcomes, including reduced hospital stays and lower mortality rates.

In a comparison of 747 patients treated before 1990 to 318 patients treated after the clinical pathway was established, there were notable decreases in both in-hospital and 1-year mortality rates, highlighting the efficacy of the new treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pathway for hip fractures in the elderly: the Hospital for Joint Diseases experience. Koval, KJ., Chen, AL., Aharonoff, GB., et al.[2019]

The implementation of a multidisciplinary geriatric hip fracture clinical pathway significantly reduced the preoperative length of hospital stay from an average of 6.1 days in 2006 to 1.5 days in 2011, indicating improved efficiency in patient management.

In addition to shorter hospital stays, the inpatient mortality rate for hip fracture patients decreased from 2.7% in 2006 to 1.25% in 2010, demonstrating enhanced safety and outcomes for elderly patients undergoing hip fracture treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a geriatric hip fracture clinical pathway in reducing hospital and rehabilitation length of stay and improving short-term mortality rates. Lau, TW., Fang, C., Leung, F.[2022]

The introduction of a virtual pathway for managing suspected scaphoid fractures resulted in high patient satisfaction, with 97% of patients reporting they were satisfied with their treatment after an average follow-up of 19 months.

Patient-reported outcome measures (PROMs) indicated excellent recovery, with a median QuickDASH score of 2.3 and no documented cases of symptomatic nonunion one year after injury, suggesting the virtual pathway is both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual management of clinically suspected scaphoid fractures. Stirling, PHC., Simpson, CJ., Ring, D., et al.[2022]

The introduction of a clinical pathway for total knee arthroplasty led to significant improvements in patient-reported outcomes, with WOMAC scores increasing by 39% in the baseline cohort and 35% in the cohort using the new pathway after 3 months.

Despite a reduction in partial costs from 4303 EUR to 419 EUR, the study did not achieve a better quality of life to cost ratio, indicating that while the clinical pathway improved treatment quality, it did not enhance cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical pathway for total knee arthroplasty. I: Pathway conception and effect on functional quality of results]. Kirschner, S., Lützner, J., Günther, KP., et al.[2021]

A pharmacist-driven osteoporosis pathway implemented at The Queen Elizabeth Hospital in 2003 has led to a remarkable 95% prescription rate for osteoporosis therapy in patients with minimal trauma fractures, demonstrating its effectiveness.

The study highlights the long-term sustainability of this clinical pathway, indicating that structured interventions can significantly improve the management of osteoporosis in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustainability of a pharmacist-driven pathway for osteoporosis-related fractures on an orthopaedic unit after a 5-year period. Lai, B., Gibb, C., Pink, J., et al.[2015]

Clinical care pathways (CCPs) significantly improve health-related quality of life (HRQoL) and physical function in patients aged 50 and older following fragility fractures, based on a systematic review of 22 studies involving 5842 participants.

CCPs that extend from inpatient to outpatient care and include features like care coordination, geriatric assessments, and rehabilitation show the greatest improvements in patient outcomes compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Clinical Care Pathways on Quality of Life and Physical Function After Fragility Fracture: A Meta-analysis. Talevski, J., Sanders, KM., Duque, G., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-complications-arthroplasty-6-2023-f7669

Bone Health Referral for Joint Replacement Surgery The goal of this clinical trial is to observe the impact of a surgeon-driven bone health referral pathway following lower extremity arthroplasty.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05845021/surgeon-initiated-bone-health-referral-pathway-in-patients-undergoing-lower-extremity-arthroplasty?state=MD&city=Columbia

Surgeon-Initiated Bone Health Referral Pathway in ... The goal of this clinical trial is to observe the impact of a surgeon-driven bone health referral pathway following lower extremity ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10427072/

Editor's Spotlight/Take 5: Can Hip and Knee Arthroplasty ... More than half of the patients who undergo THA or TKA were at high risk for developing osteoporosis based on established (and easily applied) criteria.

4. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/pdf/topic-nom-major-joint-replacement.pdf

Integrated Care Pathway for Total Joint Arthroplasty By implementing this Care Pathway, you can expect that your patients and their families will: - be more educated and engaged in their care and recovery;. - be ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352344118300074

Arthroplasty care redesign related to the Comprehensive ... The purpose of this study was to determine the efficacy and sustainability of a multidisciplinary care redesign for total joint arthroplasty under the CJR ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0053128

Complications; Arthroplasty (DBCOND0053128) Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty, No drug interventions, prevention, Not Available, recruiting.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601074/

Outcomes after joint replacement 2003 to 2022 - NCBI - NIH The main outcome analyses in this report relate to primary and revision joint replacements, unless otherwise indicated. We have included all patients with ...