Bone Health Referral for Joint Replacement Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Prior osteoporosis diagnosis, treatment
No Placebo Group
Trial Summary
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.
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.12345
Is the Bone Health Referral Pathway safe for humans?
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.2691011
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.
Trial 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 (Procedure)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Surgeon-Initiated Bone Health Referral PathwayExperimental Treatment1 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 CareActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Charter Professional CenterColumbia, MD
Loading ...
Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
References
Key interventions and outcomes in joint arthroplasty clinical pathways: a systematic review. [2019]SUMMARY RATIONALE, AIMS AND OBJECTIVES: Clinical pathways are globally used to improve quality and efficiency of care. Total joint arthroplasty patients are one of the primary target groups for clinical pathway development. Despite the worldwide use of clinical pathways, it is unclear which key interventions multidisciplinary teams select as pathway components, which outcomes they measures and what the effect of this complex intervention is. This literature study is aimed at three research questions: (1) What are the key interventions used in joint arthroplasty clinical pathways? (2) Which outcome measures are used? (3) What are the effects of a joint arthroplasty clinical pathway?
Sustainability of a pharmacist-driven pathway for osteoporosis-related fractures on an orthopaedic unit after a 5-year period. [2015]Diagnosis and management of osteoporosis in hospitals are poor. Effective medications for reducing fracture risk are often underutilised in hospital settings. Studies have shown that improvements in secondary prevention of osteoporosis can occur with the implementation of clinical pathways and are effective in improving the prescription for osteoporosis medications. We aimed to assess the long-term sustainability of the benefit of the osteoporosis pathway implemented at The Queen Elizabeth Hospital, Adelaide, Australia, in 2003.
Clinical pathway for hip fractures in the elderly: the Hospital for Joint Diseases experience. [2019]Hip fractures are common injuries in the elderly and are associated with considerable morbidity and mortality. Although technical advances in the treatment of the elderly have resulted in improved fracture fixation and surgical outcomes, clinical pathways have been developed to further improve patient outcome while shortening hospital length of stay after hip fracture. We describe the clinical pathway used since 1990 at the Hospital for Joint Diseases. The outcomes of 747 patients treated before 1990 were compared with outcomes of 318 patients treated at our hospital after initiation of the clinical pathway. Use of the clinical pathway was associated with significant decreases in the acute care hospital length of stay, in-hospital mortality, and 1-year mortality.
Effect of Clinical Care Pathways on Quality of Life and Physical Function After Fragility Fracture: A Meta-analysis. [2020]To evaluate the effect of clinical care pathways (CCPs) on health-related quality of life (HRQoL) and physical function following fragility fracture and identify the specific characteristics of CCPs that are associated with improved outcomes.
[Clinical pathway for total knee arthroplasty. I: Pathway conception and effect on functional quality of results]. [2021]The aim of the current study was to evaluate patient-centred and economic outcomes after introduction of a clinical pathway for total knee arthroplasty.
The effectiveness of a geriatric hip fracture clinical pathway in reducing hospital and rehabilitation length of stay and improving short-term mortality rates. [2022]A geriatric hip fracture clinical pathway, led by an orthopedic surgeon, was developed in 2007. This clinical pathway team is multidisciplinary and consists of surgeons, physicians, anesthetists, nurses, physiotherapists, occupational therapists, medical social workers, dieticians as well as voluntary support groups.
[Reality of treatment of osteoporotic fractures in German trauma departments. A contribution for outcome research]. [2019]The implementation of clinical pathways has a proven positive effect on the diagnostic workup and initiation of therapy in osteoporotic fracture patients. Unlike in most countries, fracture care in Germany is provided by so-called trauma surgeons. Therefore, it is essential to focus on the trauma surgeon for correct diagnostic workup and therapy initiation after a fragility fracture. A questionnaire was mailed to 409 departments of traumatology inquiring about the existence of a standardized clinical pathway for diagnosis and treatment of patients with fragility fractures. One of the central issues of the survey was whether those pathways comply with national guidelines. Only institutions that stated that they followed a clinical pathway were analyzed. 80% of institutions took part in our survey, 35% of which reported following a defined clinical pathway. Diagnostic workup is in concordance with the national guidelines in 30%, and therapy is guideline-based in 51%, with 12% basing both diagnostic workup and therapy on the guidelines. Thus, the vast majority of German traumatology departments do not follow national guidelines regarding osteoporosis diagnostics and therapy in patients with fragility fractures, leading to a great opportunity to improve fragility fracture care by means of both education and interdisciplinary cooperation.
Virtual management of clinically suspected scaphoid fractures. [2022]The aim of this study was to describe the introduction of a virtual pathway for the management of patients with a suspected fracture of the scaphoid, and to report patient-reported outcome measures (PROMs) and satisfaction following treatment using this service.
The journey to total hip or knee replacement. [2014]Despite the incidence of joint replacements in Australia, there is a paucity of information regarding how patients progress from their referral to their surgery. The aim of this study was to describe a patient pathway from referral to receipt of total hip replacement (THR) or total knee replacement (TKR) surgery in South Australian public hospitals.
The Alberta Hip and Knee Replacement Project: a model for health technology assessment based on comparative effectiveness of clinical pathways. [2009]The Alberta Hip and Knee Replacement Project developed a new evidence-based clinical pathway (NCP) for total hip (THR) and knee (TKR) replacement. The aim was to facilitate the delivery of services in a timely and cost-effective manner while achieving the highest quality of care for the patient across the full continuum of care from patient referral to an orthopedic surgeon through surgery, recovery, and rehabilitation. The purpose of this article is to provide an overview of the study design, rationale, and execution of this project as a model for health technology assessment based on comparative effectiveness of alternative clinical pathways.
Optimizing Outcomes By Optimizing Bone Health. [2022]Orthopaedic surgeons have long been aware of the importance of metabolic bone health for fracture healing; however, recent attention has focused on optimization of bone health before elective surgery and also regarding pathways to ensure patients have appropriate evaluation and treatment for bone health issues. It is important to describe issues of importance to fragility fracture care and prevention and optimization of outcomes before elective or fracture surgery. To address the challenge of who has the time, expertise, and appropriate patient contact to identify and treat patients at risk of bone metabolic issues, one model for a suggested pathway to ensure these patients are identified and treated is outlined.