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

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.

What data supports the effectiveness of the treatment Surgeon-Initiated Bone Health Referral Pathway, Bone Health Referral Pathway, Surgeon-Driven Bone Health Referral Pathway for joint replacement surgery?

Research shows that clinical pathways, like those used for joint replacement surgery, can improve patient outcomes by reducing hospital stay and mortality rates. Additionally, pathways for osteoporosis have been effective in increasing the use of medications that reduce fracture risk, suggesting that structured referral pathways can enhance bone health management. ^{1 2 3 4 5}

Is the Bone Health Referral Pathway safe for humans?

The research on clinical pathways for bone health, such as those for osteoporosis and fragility fractures, suggests they are generally safe and can improve care by ensuring proper diagnosis and treatment, although specific safety data for the Bone Health Referral Pathway is not detailed. ^{2 4 6 7 8}

How is the Surgeon-Initiated Bone Health Referral Pathway treatment different from other treatments for joint replacement surgery?

The Surgeon-Initiated Bone Health Referral Pathway is unique because it involves a proactive approach by surgeons to ensure patients are evaluated and treated for bone health issues before joint replacement surgery, which is not typically part of standard care. This pathway emphasizes the importance of optimizing bone health to improve surgical outcomes and involves a multidisciplinary team to address bone health comprehensively. ^{2 6 9 10 11}

What is the purpose of this trial?

The goal of this clinical trial is to observe the impact of a surgeon-driven bone health referral pathway following lower extremity arthroplasty. The main question this study aims to answer is: 1) What is impact of a surgeon-driven bone health referral pathway on implant-related complications and fragility fractures when compared to standard of care primary care provider referral. Researchers will compare the endocrinology referral pathway and standard of care to see if there is a difference in treatment rates, fragility fractures, and implant-related complications following lower extremity arthroplasty.

Research Team

Savyasachi Thakkar, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Key interventions and outcomes in joint arthroplasty clinical pathways: a systematic review. [2019]

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

Sustainability of a pharmacist-driven pathway for osteoporosis-related fractures on an orthopaedic unit after a 5-year period. [2015]

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

Clinical pathway for hip fractures in the elderly: the Hospital for Joint Diseases experience. [2019]

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

Effect of Clinical Care Pathways on Quality of Life and Physical Function After Fragility Fracture: A Meta-analysis. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

[Clinical pathway for total knee arthroplasty. I: Pathway conception and effect on functional quality of results]. [2021]

6. United States 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. [2022]

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

[Reality of treatment of osteoporotic fractures in German trauma departments. A contribution for outcome research]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Virtual management of clinically suspected scaphoid fractures. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

The journey to total hip or knee replacement. [2014]

10. England 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. [2009]

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

Optimizing Outcomes By Optimizing Bone Health. [2022]