Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416618
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-08
Brief Title:
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
Sponsor:
Zealand University Hospital
Organization:
Zealand University Hospital
Study Overview
Official Title:
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years a Pragmatic Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
PHF50-65
Brief Summary:
The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture
The main questions it aims to answer are
Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up
Aim is also to characterize the patient group aged 50-65 regarding fracture morphology osteoporosis and clinical frailty scale
The study compare operation with either plate or nail fixation to non-surgical treatment
Participants will
Receive either surgical treatment or non-surgical treatment
At 6 months 1 year and 2 years the patient will answer two short questionnaires Oxford Shoulder Score and Eq-5D-3L
The primary outcome will be Oxford Shoulder Score at 12 months The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points Adverse events and conversion to surgery will be registered OSS and EQ-5D-3L will be completed just before the 6 months visit
The main questions it aims to answer are
Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up
Aim is also to characterize the patient group aged 50-65 regarding fracture morphology osteoporosis and clinical frailty scale
The study compare operation with either plate or nail fixation to non-surgical treatment
Participants will
Receive either surgical treatment or non-surgical treatment
At 6 months 1 year and 2 years the patient will answer two short questionnaires Oxford Shoulder Score and Eq-5D-3L
The primary outcome will be Oxford Shoulder Score at 12 months The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points Adverse events and conversion to surgery will be registered OSS and EQ-5D-3L will be completed just before the 6 months visit
Detailed Description:
Proximal humerus fractures PHF are common injuries At the age of 60 and above no clinically important difference between surgical and non-surgical treatment after one year has been reported based on a recent Cochrane review of 10 trials
The treatment of choice for displaced PHF in adults 50-65 years is anatomical reconstruction and osteosynthesis if possible which is why many patients in this age group with a displaced PHF undergo surgical treatment
Orthopaedic surgeons may encounter challenges in guiding patients and formulating treatment strategies within specific age groups due to the absence of inclusion of this younger patient demographic in existing evidence Knowledge is primarily derived from studies on the population aged 60 years and above There exists an intermediate age group of patients for whom it remains uncertain whether the benefits and harms of non-surgical and surgical interventions are comparable
This trial is a two-center parallel-group randomized superiority trial comparing osteosynthesis with non-surgical treatment following a displaced proximal humerus fractures in patients aged 50-65 years The participants will be included and allocated equally to surgical treatment with osteosynthesis comparator with non-surgical treatment intervention
The surgical group will visit the outpatient clinic after 2 12 and 24 weeks while the non-surgical group will visit after 6 12 and 24 weeks X-rays will be obtained before every visit
Both groups will be referred to rehabilitation in the municipalities
Without a patient-derived MCID for PHF a relevant difference of 96 was assumed to represent clinically meaningful difference This is equivalent to approximately a 20 difference between the surgical group and the non-surgical group on a 0-48 OSS scale With a power of 80 and a 5 level of significance a sample size of 25 participants per group is required Assuming a 15 loss to follow-up the recruitment target is 30 patients in each group meaning 60 participants overall
In case of treatment failure in either group defined as persistent pain or a failed osteosynthesis a salvage procedure with secondary osteosynthesis or a reverse shoulder arthroplasty RSA will be offered
Additionally there are plans for a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial decliner cohort and their baseline characteristics treatment preferences The decliner cohort will receive the same treatment follow-up and outcome measurements as the included patients
Statistical analysis
For the primary outcome a two-sample t-test will be used P-value 005 For secondary outcome - considering the hierarchical nature of the data - clustered and repeated measure data - linear mixed models will be utilized for the statistical analysis
Salvage procedures and adverse events will be reported descriptively Reoperation in the form of amotio will be considered a complication and therefore not included in the statistics of salvage procedures The time of salvage procedures in both groups will be recorded and analysed using the Cox proportional hazard model
As suggested in the extension of the CONSORT 2010 statement the primary endpoints will be analysed for the intention-to-treat ITT population and for sensitivity reasons for the per-protocol PP population There will be two analyses for both ITT and PP populations one including salvage procedures and one excluding them These analyses will be used to evaluate the occurrence of salvage procedures and the interventions effect
The length of rehabilitation will be presented with a mean and standard division for each of the groups Differences in adherence to rehabilitation within the groups will be reported using the chi-squared test Linear mixed models will be employed to test whether adherence to rehabilitation modifies the effect of the groups
All statistical analyses will also be conducted for the decliner cohort including a comparison of the primary outcome between those with a preference for surgical treatment and those with a preference for non-surgical treatment
The treatment of choice for displaced PHF in adults 50-65 years is anatomical reconstruction and osteosynthesis if possible which is why many patients in this age group with a displaced PHF undergo surgical treatment
Orthopaedic surgeons may encounter challenges in guiding patients and formulating treatment strategies within specific age groups due to the absence of inclusion of this younger patient demographic in existing evidence Knowledge is primarily derived from studies on the population aged 60 years and above There exists an intermediate age group of patients for whom it remains uncertain whether the benefits and harms of non-surgical and surgical interventions are comparable
This trial is a two-center parallel-group randomized superiority trial comparing osteosynthesis with non-surgical treatment following a displaced proximal humerus fractures in patients aged 50-65 years The participants will be included and allocated equally to surgical treatment with osteosynthesis comparator with non-surgical treatment intervention
The surgical group will visit the outpatient clinic after 2 12 and 24 weeks while the non-surgical group will visit after 6 12 and 24 weeks X-rays will be obtained before every visit
Both groups will be referred to rehabilitation in the municipalities
Without a patient-derived MCID for PHF a relevant difference of 96 was assumed to represent clinically meaningful difference This is equivalent to approximately a 20 difference between the surgical group and the non-surgical group on a 0-48 OSS scale With a power of 80 and a 5 level of significance a sample size of 25 participants per group is required Assuming a 15 loss to follow-up the recruitment target is 30 patients in each group meaning 60 participants overall
In case of treatment failure in either group defined as persistent pain or a failed osteosynthesis a salvage procedure with secondary osteosynthesis or a reverse shoulder arthroplasty RSA will be offered
Additionally there are plans for a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial decliner cohort and their baseline characteristics treatment preferences The decliner cohort will receive the same treatment follow-up and outcome measurements as the included patients
Statistical analysis
For the primary outcome a two-sample t-test will be used P-value 005 For secondary outcome - considering the hierarchical nature of the data - clustered and repeated measure data - linear mixed models will be utilized for the statistical analysis
Salvage procedures and adverse events will be reported descriptively Reoperation in the form of amotio will be considered a complication and therefore not included in the statistics of salvage procedures The time of salvage procedures in both groups will be recorded and analysed using the Cox proportional hazard model
As suggested in the extension of the CONSORT 2010 statement the primary endpoints will be analysed for the intention-to-treat ITT population and for sensitivity reasons for the per-protocol PP population There will be two analyses for both ITT and PP populations one including salvage procedures and one excluding them These analyses will be used to evaluate the occurrence of salvage procedures and the interventions effect
The length of rehabilitation will be presented with a mean and standard division for each of the groups Differences in adherence to rehabilitation within the groups will be reported using the chi-squared test Linear mixed models will be employed to test whether adherence to rehabilitation modifies the effect of the groups
All statistical analyses will also be conducted for the decliner cohort including a comparison of the primary outcome between those with a preference for surgical treatment and those with a preference for non-surgical treatment
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