Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303284
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-04
Brief Title:
Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures A Pilot RCT
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures A Pilot RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures so does the risk of post-surgical complications Prevention of post-surgical complications is of paramount importance to reducing morbidity mortality and healthcare costs
There is growing evidence to support the use of bone-building medications such as Teriparatide in patients who have delayed fracture healing or non-unions however these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications
The proposed study is a pilot randomized controlled trial RCT with patients 60 years or older with an additional risk factor for delayed healing ie osteoporosis diabetes vascular disease who require ankle fracture surgery Participants will be randomized to receive the study medication Teriparatide or placebo for three months The primary objective of this study is to acquire vital data ie recruitment rates follow-up rates adherence to treatment assignment required to determine the feasibility of a full-scale multi-centre RCT Additional aims are to evaluate repeat surgery complications time-to-union and 90-day mortality A complete a socio-economic and feasibility analysis will be completed
This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength thereby improving bone health preventing complications and improving outcomes This study will also inform planning for a larger clinical trial to reduce the morbidity mortality and cost associated with complications in this high-risk population
There is growing evidence to support the use of bone-building medications such as Teriparatide in patients who have delayed fracture healing or non-unions however these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications
The proposed study is a pilot randomized controlled trial RCT with patients 60 years or older with an additional risk factor for delayed healing ie osteoporosis diabetes vascular disease who require ankle fracture surgery Participants will be randomized to receive the study medication Teriparatide or placebo for three months The primary objective of this study is to acquire vital data ie recruitment rates follow-up rates adherence to treatment assignment required to determine the feasibility of a full-scale multi-centre RCT Additional aims are to evaluate repeat surgery complications time-to-union and 90-day mortality A complete a socio-economic and feasibility analysis will be completed
This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength thereby improving bone health preventing complications and improving outcomes This study will also inform planning for a larger clinical trial to reduce the morbidity mortality and cost associated with complications in this high-risk population
Detailed Description:
Background Delayed healing implant failure loss of reduction and infection rates are common post-operative complications following ankle fracture fixation among patients aged 60 years or older with compromised soft tissue andor metabolic challenges There is growing evidence to support the safety and efficacy of using anabolic agents in achieving osseous union in the setting of delayed fracture healing and nonunion Teriparatide has been prescribed for the treatment of osteoporosis with very few serious adverse events reported Therefore the goals of the proposed research are to examine the safety and efficacy of Teriparatide use for high-risk acute ankle fractures and to determine the feasibility of a full-scale trial This new knowledge will inform the implementation of Teriparatide for improved fracture healing
Specific Aims SA The investigators hypothesize that the short-term use of the anabolic agent Teriparatide will augment fracture fixation and result in lower complication rates Our specific aims include SA1 Evaluate the feasibility of a definitive full-scale randomized controlled trial comparing Teriparatide with a placebo SA2 Compare the post-operative complication rate between short-term augmentation with Teriparatide and a placebo and SA3 Evaluate the safety and efficacy of Teriparatide use
Methods This study is a multi-center double-blinded pilot randomized controlled trial RCT with patients 60 years or older with an additional risk factor for delayed healing ie osteoporosis diabetes vascular disease who require ankle fracture surgery Participants will be randomized to receive the study medication Teriparatide or placebo for three months The primary objective of this study is to acquire vital data ie recruitment rates follow-up rates adherence to treatment assignment required to determine the feasibility of a full-scale multi-center RCT Additional aims are to evaluate repeat surgery complications time-to-union and 90-day mortality A complete a socio-economic and feasibility analysis will be completed
Significance Delayed healing implant failure loss of reduction and infection rates continue to be devastating complications of ankle fracture fixation that profoundly impact patients and their families surgeons and the healthcare system It is imperative that the investigators evaluate innovative strategies for improving outcomes for these high-risk patients The multi-disciplinary team of investigators has designed this project to generate new knowledge about the safety and efficacy of using Teriparatide in the acute fracture setting in order to reduce complications morbidity and mortality in this vulnerable population By addressing knowledge gaps and promoting evidence-based education and interventions the project aims to have a sustainable impact on scientific knowledge clinical practice and ultimately the well-being of elderly patients undergoing ankle fracture fixation
Specific Aims SA The investigators hypothesize that the short-term use of the anabolic agent Teriparatide will augment fracture fixation and result in lower complication rates Our specific aims include SA1 Evaluate the feasibility of a definitive full-scale randomized controlled trial comparing Teriparatide with a placebo SA2 Compare the post-operative complication rate between short-term augmentation with Teriparatide and a placebo and SA3 Evaluate the safety and efficacy of Teriparatide use
Methods This study is a multi-center double-blinded pilot randomized controlled trial RCT with patients 60 years or older with an additional risk factor for delayed healing ie osteoporosis diabetes vascular disease who require ankle fracture surgery Participants will be randomized to receive the study medication Teriparatide or placebo for three months The primary objective of this study is to acquire vital data ie recruitment rates follow-up rates adherence to treatment assignment required to determine the feasibility of a full-scale multi-center RCT Additional aims are to evaluate repeat surgery complications time-to-union and 90-day mortality A complete a socio-economic and feasibility analysis will be completed
Significance Delayed healing implant failure loss of reduction and infection rates continue to be devastating complications of ankle fracture fixation that profoundly impact patients and their families surgeons and the healthcare system It is imperative that the investigators evaluate innovative strategies for improving outcomes for these high-risk patients The multi-disciplinary team of investigators has designed this project to generate new knowledge about the safety and efficacy of using Teriparatide in the acute fracture setting in order to reduce complications morbidity and mortality in this vulnerable population By addressing knowledge gaps and promoting evidence-based education and interventions the project aims to have a sustainable impact on scientific knowledge clinical practice and ultimately the well-being of elderly patients undergoing ankle fracture fixation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None