Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868305
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2021-04-06
Brief Title:
Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures
Sponsor:
Helse Stavanger HF
Organization:
Helse Stavanger HF
Study Overview
Official Title:
Randomized Clinical Trial Treatment of Unstable Trochanteric Hip Fractures With Intramedullary Nail Versus Hip Arthroplasty Survival Complications and Postoperative Patient Reported Outcomes
Status:
RECRUITING
Status Verified Date:
2023-11
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:
TUFHIPRCT
Brief Summary:
A hip fracture is a large burden to the patient with increased mortality pain and increased need for daily assistance Trochanteric fractures of the femur FTF represents about 35 of the hip fractures Today FTFs are mainly treated with internal fixation using sliding hips screws SHS or intramedullary nail IMN whilst hip arthroplasty THAHA is rarely used Despite advances in the design of the internal fixation implants there is a high failure rate in particular in cases of FTFs classified as unstable fractures Since the introduction of hip arthroplasty in femoral neck fractures there has been a reduction in complication rates early mobilization and shorter hospital stays
The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility give a better general health outcome for the patient better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN
The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility give a better general health outcome for the patient better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN
Detailed Description:
Proximal femoral fractures also termed hip fractures are one of the most common fractures among adults over 50 years of age With increase in life expectancy the incidence of these fractures is also increasing By 2040 the number of these fractures are expected to double in Norway Trochanteric fractures of the femur Fractura Trochanterica Femoris FTF represents about 35 of the hip fractures in Norway There are many classification systems for FTFs but The Orthopaedic Trauma Association OTA have adopted the system developed by the Arbeitsgemeinschaft Osteosynthese AO group and is the most commonly used in addition to the Evans Jensens classification
The mean age of hip fracture patients is 82 years for women and 78 for men The comorbidity in this patient group is high with large amount of dementia sarcopenia and osteoporosis The one-year mortality rate after a hip fractures is 20-35 According to the Norwegian Hip Fracture Register 15 of the hip fractures are unstable trochanteric fractures AO 31A22-A3 The prognosis is poor in particular for unstable multi fragmented fractures with reported complications up to 35-51
Substantial research has established better understanding and best practice guidelines to treat the femoral neck fractures mostly with hip arthroplasty however no superior method is established for the unstable trochanteric fractures Getting It Right First Time is important for these fragile patients thus post-operative complications are associated with a large increase in the mortality
Today most of the FTFs are reduced and fixated with a sliding hip screw SHS although the use of intramedullary nails IMN is increasing RCTs have shown better survival of IMN compared to SHS for the more distal FTFs and subtrochanteric fracture Unstable FTFs AO 31A2 - A3 EVJ III-V have high reoperation rates 21-35 when operated either with SHS or IMN Unacceptable shortening external rotation deformity of the limb and long time to recovermobilization have been the problems with osteosynthesis
The question is if hip arthroplasty can give a superior treatment outcome for patients suffering from unstable subtypes of trochanteric hip fractures compared to the traditional treatment with IMN A randomized clinical trial is to be conducted comparing these two treatment methodologies
Stavanger University Hospital SUH receives over 150 FTFs per year About 13 of the FTFs are of unstable fracture morphology The planned study is a randomized clinical trial The randomization module will be provided by Klinisk forskningsenhet Midt-Norge KlinForsk Patients fulfilling the inclusion criteria will be randomized to one of two treatment groups IMN versus hip arthroplasty
Included patients will be treated in accordance to a local operation protocol
Intramedullary nails will be operated by a resident orthopedic surgeon with at least 2 years experience in fracture surgery or a consultant orthopedic surgeon there must always be a consultant orthopedic surgeon present in the surgical team A long IMN must always be utilized Anatomical reposition or positive anterior and medial cortical support should be strived to be achieved If a large antero- or posteromedial fragment is present one should consider an additional cerclage to fix the fragment
Arthroplasty will be operated by a resident orthopedic surgeon with at least 2 years experience with hip arthroplasty surgery or by a consultant orthopedic surgeon subspecialized in arthroplasty surgery with competency within revision or difficult primary hip arthroplasty surgery there must always be a consultant orthopedic surgeon subspecialized in arthroplasty surgery present in the surgical team Posterior surgical approach will be used If a cup is to be utilized it must be a cemented dual-mobility cup
The patients will have follow-up appointments at 2- 6 and 12 months postoperative Following data will be collected
Patient reported outcome measures HOOS and EQ5D
Timed up and go test
Trendelenburg test
Clinical leg length discrepancy
Radiological assessment from hip x-rays AP and lateral
The mean age of hip fracture patients is 82 years for women and 78 for men The comorbidity in this patient group is high with large amount of dementia sarcopenia and osteoporosis The one-year mortality rate after a hip fractures is 20-35 According to the Norwegian Hip Fracture Register 15 of the hip fractures are unstable trochanteric fractures AO 31A22-A3 The prognosis is poor in particular for unstable multi fragmented fractures with reported complications up to 35-51
Substantial research has established better understanding and best practice guidelines to treat the femoral neck fractures mostly with hip arthroplasty however no superior method is established for the unstable trochanteric fractures Getting It Right First Time is important for these fragile patients thus post-operative complications are associated with a large increase in the mortality
Today most of the FTFs are reduced and fixated with a sliding hip screw SHS although the use of intramedullary nails IMN is increasing RCTs have shown better survival of IMN compared to SHS for the more distal FTFs and subtrochanteric fracture Unstable FTFs AO 31A2 - A3 EVJ III-V have high reoperation rates 21-35 when operated either with SHS or IMN Unacceptable shortening external rotation deformity of the limb and long time to recovermobilization have been the problems with osteosynthesis
The question is if hip arthroplasty can give a superior treatment outcome for patients suffering from unstable subtypes of trochanteric hip fractures compared to the traditional treatment with IMN A randomized clinical trial is to be conducted comparing these two treatment methodologies
Stavanger University Hospital SUH receives over 150 FTFs per year About 13 of the FTFs are of unstable fracture morphology The planned study is a randomized clinical trial The randomization module will be provided by Klinisk forskningsenhet Midt-Norge KlinForsk Patients fulfilling the inclusion criteria will be randomized to one of two treatment groups IMN versus hip arthroplasty
Included patients will be treated in accordance to a local operation protocol
Intramedullary nails will be operated by a resident orthopedic surgeon with at least 2 years experience in fracture surgery or a consultant orthopedic surgeon there must always be a consultant orthopedic surgeon present in the surgical team A long IMN must always be utilized Anatomical reposition or positive anterior and medial cortical support should be strived to be achieved If a large antero- or posteromedial fragment is present one should consider an additional cerclage to fix the fragment
Arthroplasty will be operated by a resident orthopedic surgeon with at least 2 years experience with hip arthroplasty surgery or by a consultant orthopedic surgeon subspecialized in arthroplasty surgery with competency within revision or difficult primary hip arthroplasty surgery there must always be a consultant orthopedic surgeon subspecialized in arthroplasty surgery present in the surgical team Posterior surgical approach will be used If a cup is to be utilized it must be a cemented dual-mobility cup
The patients will have follow-up appointments at 2- 6 and 12 months postoperative Following data will be collected
Patient reported outcome measures HOOS and EQ5D
Timed up and go test
Trendelenburg test
Clinical leg length discrepancy
Radiological assessment from hip x-rays AP and lateral
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?:
None
Is an FDA AA801 Violation?:
None