Hip InjuriesREHABNCT06212622
Is the Rate of Early Mobilisation in Hip Fracture Patients Using Alfentanil Better Than Standard Opioid Analgesia?
An observational study of Hip Injuries and Hip Fractures, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
Hip fracture injuries are linked with increased morbidity, frailty, and mortality risk. Studies have shown that in hip fracture surgery, early mobilisation confers better pain control, 30-day complication and mortality rates and could reduce in hospital length of stay. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Injuries, Hip Fractures, Pain
- What is being tested?
- Alfentanil and Oxycodone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2024to 18 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants listed for urgent hip fracture surgery, after sustaining a hip fracture surgery under the care of participating surgeons at the institution of RIE. 64 participants will be included in this prospective cohort study, 32 in each cohort. There will be consecutively recruitment and follow all hip fracture patients admitted over a month at RIE.
Who may be able to join
- Listed for urgent hip fracture surgery - dynamic hip screw/cannulated hip screw/hemiarthroplasty/total hip arthroplasty/intramedullary nail
- Sustained an insufficiency/low energy type hip fracture
- Male or female aged over 60
- Able to provide informed consent
Who cannot join
- Pathological or periprosthetic hip fracture
- Mechanism of injury for hip fracture was of high energy
- Patient is unable to comply with the study protocol or functional assessments
- Patients aged less than 60
- Patients who were wheelchair bound prior to injury
- Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Enrolment in existing research studies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
About this study
Official title: Is the Rate of Early Mobilisation in Hip Fracture Patients Using Alfentanil Better Than Standard Opioid Analgesia (REHAB): a Prospective Cohort Study
Hip fracture injuries are linked with increased morbidity, frailty, and mortality risk. Studies have shown that in hip fracture surgery, early mobilisation confers better pain control, 30-day complication and mortality rates and could reduce in hospital length of stay.
Though early mobilisation may provide numerous post operative benefits, there are barriers to achieving this reliably and effectively. One such difficulty is pain.
Read more
In the Royal Infirmary of Edinburgh (RIE) like many boards across Scotland, oral oxycodone has been routinely used as analgesia to help with post operative pain, in patients who have undergone orthopaedic trauma injuries. However, this analgesic modality is utilised to help with general post operative pain, rather than targeted abolition of pain prior to physiotherapy.
Alfentanil is a relatively new medication which has a very rapid onset of action and short half life. Alfentanil may prove to be a superior form of analgesia for the purpose of encouraging early mobilisation after hip fracture surgery. This study could provide robust evidence for regular use of alfentanil prior to physiotherapy in early post operative hip fracture surgery patients.
Read the detailed description
Hip fractures are amongst the most common orthopaedic injuries. These fractures predominantly occur in the elderly population, secondary to osteoporosis. Projection studies from across the world suggest that incidence rates of hip fractures are set to increase. Worldwide projections indicate that hip fracture cases will double from 1.26 million in 1990, to 2.6 million by 2025, and to 4.5 million by 2050. The National Joint Registry reports that the number of hip fractures have increased from 1,371 in 2010 to 84,998 in 2021 across England, Wales and Northern Ireland. The Scottish Hip Fracture Audit identifies an increase from 6,369 hip fracture cases in 2007 to 8,380 in 2022. Given the exponential rise in the frail elderly population, these numbers will only further rise in the future.
Hip fracture injuries are linked with increased morbidity, frailty, and mortality risk. Moreover, there is significant social and economic costs on the healthcare system stemming from these injuries. In the United States, these costs are greater than $5.96 billion, annually. In the United Kingdom, these costs are approximately £1.1 billion. Healthcare systems globally, are becoming progressively more financially restrained, and the incidence of hip fractures are set to increase. Thus, further emphasis should be placed on interventions to reduce morbidity and mortality in this frail elderly patient group.
Many studies have shown that early mobilisation after hip fracture surgery provides reduced post operative pain and complication rates and reduces length of stay (LOS) in hospital. Some studies have demonstrated that early ambulation reduces 30-day mortality rates in this patient population. It has been demonstrated that early mobilisation was also associated with an increased rate of discharges directly home, compared to those patients who mobilised late. Although elderly patients have associated co-morbidity and a higher risk of delirium, neither factors influenced inability to mobilise early after surgery. They also found that a greater number of patients who mobilised early were able to be discharged directly home.
Though early mobilisation may provide numerous post operative benefits, there are barriers to achieving this reliably and effectively. One such difficulty is pain. Studies report that pain is often a key obstacle to early ambulation after surgery. In the Royal Infirmary of Edinburgh (RIE) like many boards across Scotland, oral oxycodone has been routinely used as analgesia to help with post operative pain, in patients who have undergone orthopaedic trauma injuries. However, this analgesic modality is utilised to help with general post operative pain, rather than targeted abolition of pain prior to physiotherapy.
Oxycodone has been utilised in clinical practice since 1917. There is in depth literature on the pharmacokinetics of oxycodone. The onset of action of oral oxycodone is between 10-30 minutes. Peak onset occurs around 1 hour. Plasma half-life is 3-5 hours, regardless of route of administration.
On the other hand, alfentanil is relatively new, and the literature is scarce on its pharmacokinetic properties. There is consensus amongst the literature that onset of action of alfentanil is very rapid, with peak onset of intravenous alfentanil as quick as 2 minutes. Plasma half-life of oral alfentanil is 1-2 hours. Moreover, side effects of respiratory depression are lower than that from fentanyl or sufentanil. The combination of rapid onset of pain relief, with an equally quick excretion, makes this medication appealing in palliative care medicine, in which patients are typically frail. This is particularly the case in patients with renal impairment since this medication is excreted by the liver.
Alfentanil may prove to be a superior form of analgesia for the purpose of encouraging early mobilisation after hip fracture surgery.
- Conditions
- Hip Injuries, Hip Fractures, Pain, Post Operative Pain, Early Ambulation
- Being tested
- Alfentanil, Oxycodone
- Keywords
- early mobilisation, hip fracture, pain, oxycodone, alfentanil, ambulation
- Medical subject headings
- Hip Injuries, Hip Fractures, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfentanilDrug
Subcutaneous injection
OxycodoneDrug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| STANDARD CARE WITH ORAL OXYCODONE | These patients will receive oral oxycodone prior to their post operative day 1 and 2 physiotherapy sessions
The dose is age dependent (and also on frailty status):
< 65 years old: Oxycodone 5mg immediate release
65 - 85 years old: Oxycodone 4mg immediate release
> 85 years old: Oxycodone 3mg immediate release
<50kg or particularly frail: Oxycodone 2mg immediate release Receives: Drug: Oxycodone | |
| INTERVENTION GROUP WITH SUBCUTANEOUS ALFENTANIL | These patients will receive subcutaneous alfentanil prior to their post operative day 1 and 2 physiotherapy sessions
This is 100 micrograms as a subcutaneous injection Receives: Drug: Alfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale score
Pain assessment using the visual analogue scale. This is a visual scale measured from 0 to 10, where 0 is no pain and 10 is very severe pain.
Measured: On post operative day 1
Ability to mobilise
Ability to mobilise based on pre assigned physiotherapy levels (PT):
- PT level 1 -> standing transfer: ability to weight bear on both legs, and transferring from bed to chair without stepping. Equipment will be utilised to help the patient swing round from bed to chair (sara steady/sam hall turner)
- PT level 2 -> stepping transfer: ability to weight bear on both legs, and transferring from bed to chair with stepping. Equipment will be utilised to help support the patient when stepping (gutter frame/Zimmer frame)
- PT level 3A -> mobilising to the toilet with assistance of two people
- PT level 3B -> mobilising to the toilet with assistance of one person
- PT level 3C -> mobilising to the toilet without assistance
Measured: On post operative day 1
Secondary outcomes (7)
Visual analogue scale score
Pain assessment using the visual analogue scale. This is a visual scale measured from 0 to 10, where 0 is no pain and 10 is very severe pain.
Measured: On post operative day 2
Ability to mobilise
Ability to mobilise based on pre assigned physiotherapy levels (PT):
- PT level 1 -> standing transfer: ability to weight bear on both legs, and transferring from bed to chair without stepping. Equipment will be utilised to help the patient swing round from bed to chair (sara steady/sam hall turner)
- PT level 2 -> stepping transfer: ability to weight bear on both legs, and transferring from bed to chair with stepping. Equipment will be utilised to help support the patient when stepping (gutter frame/Zimmer frame)
- PT level 3A -> mobilising to the toilet with assistance of two people
- PT level 3B -> mobilising to the toilet with assistance of one person
- PT level 3C -> mobilising to the toilet without assistance
Measured: On post operative day 2
EuroQol five dimension (EQ-5D) - 5L patient reported outcome measure
The EQ-5D-5L consists of questions in domains of mobility, self-care, usual activities of daily living, pain/discomfort and anxiety/depression. There are five options for marking severity for each domain. There is also a VAS, rating how the patient perceives health related quality of life from 0-100.
Measured: At post operative day (POD) 1, POD2, POD 7 and POD 30
In hospital length of stay
In hospital length of stay will be calculated as the number of days in hospital, from the date of admission to the day of discharge.
Measured: From date of admission until the date of discharge from hospital or date of death, whichever came first (assessed up to 52 weeks)
Total use of analgesia over post operative day 1 and post operative day 2
This outcome will be assessed to determine if early mobilisation helps reduce overall postoperative pain during in hospital admission, and see if differing analgesic modalities has any effect on this.
Measured: post operative day 1 and post operative day 2
Complication rates and 30-day mortality
Each patient will be followed up, via their internal TRAKcare patient notes to determine 30-day mortality. Complication rates will be assessed at POD 1, POD 2 and POD 7 alongside the EQ-5D-5L questionnaire. They will also then be followed up at 30 days to assess any further complications. The following complications will be assessed:
- Any complication
- Post operative delirium
- Surgical site infection
- Wound dehiscence
- Pneumonia
- Pulmonary embolism
- Acute kidney injury
- Urinary tract infection
- Cerebrovascular accident
- Cardiac arrest
- Myocardial infarction
- Deep vein thrombosis
- Delirium
- Sepsis
- Mortality
- Dislocation
- Re-operation (and reason for this)
- Readmission (and reason(s) for this)
Measured: At post operative day (POD) 1, POD2, POD 7 and POD 30
Discharge destination
The discharge destination will be sought, and compared with pre-admission status (e.g. at home/care home/residual home), to determine if analgesic modality affects discharge destination
Measured: Pre admission location will be assessed on the date of admission. Discharge destination will be sought, on the date of discharge from hospital (assessed up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start4 Mar 2024
- Primary completion18 Jun 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nicholas Clement, MBBS, MD, PhD, FRCS (T&O), Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212622
- Sponsor's protocol ID
- AC23143
- Acronym
- REHAB
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cummings SR, Black DM, Nevitt MC, Browner W, Cauley J, Ensrud K, Genant HK, Palermo L, Scott J, Vogt TM. Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group. Lancet. 1993 Jan 9;341(8837):72-5. doi: 10.1016/0140-6736(93)92555-8.
PubMed 8093403Kazley J, Bagchi K. Femoral Neck Fractures. StatPearls [Internet]. 2023 May 8 [cited 2023 Sep 1]; Available from: https://www.ncbi.nlm.nih.gov/books/NBK537347/
Brittain R, Howard P, Lawrence S, Stonadge J, Wilkinson M, Wilton T, et al. NJR statistical analysis, support and associated services National Joint Registry | 19th Annual Report. [cited 2023 Sep 1]; Available from: www.njrcentre.org.uk
Health Scotland P. Scottish Hip Fracture Audit Report 2023 Reporting on episodes of hip fractures in 2022 A Management Information release for Scotland
Scottish Hip Fracture Audit Report 2008 Contents. 2006 [cited 2023 Sep 1]; Available from: www.shfa.scot.nhs.uk
Kingston A, Comas-Herrera A, Jagger C; MODEM project. Forecasting the care needs of the older population in England over the next 20 years: estimates from the Population Ageing and Care Simulation (PACSim) modelling study. Lancet Public Health. 2018 Sep;3(9):e447-e455. doi: 10.1016/S2468-2667(18)30118-X. Epub 2018 Aug 31.
PubMed 30174210Downey C, Kelly M, Quinlan JF. Changing trends in the mortality rate at 1-year post hip fracture - a systematic review. World J Orthop. 2019 Mar 18;10(3):166-175. doi: 10.5312/wjo.v10.i3.166. eCollection 2019 Mar 18.
PubMed 30918799Gdalevich M, Cohen D, Yosef D, Tauber C. Morbidity and mortality after hip fracture: the impact of operative delay. Arch Orthop Trauma Surg. 2004 Jun;124(5):334-40. doi: 10.1007/s00402-004-0662-9. Epub 2004 Apr 17.
PubMed 15095097Schnell S, Friedman SM, Mendelson DA, Bingham KW, Kates SL. The 1-year mortality of patients treated in a hip fracture program for elders. Geriatr Orthop Surg Rehabil. 2010 Sep;1(1):6-14. doi: 10.1177/2151458510378105.
PubMed 23569656Adeyemi A, Delhougne G. Incidence and Economic Burden of Intertrochanteric Fracture: A Medicare Claims Database Analysis. JB JS Open Access. 2019 Feb 27;4(1):e0045. doi: 10.2106/JBJS.OA.18.00045. eCollection 2019 Mar 27.
PubMed 31161153Christodoulou C, Cooper C. What is osteoporosis? Postgrad Med J. 2003 Mar;79(929):133-8. doi: 10.1136/pmj.79.929.133.
PubMed 12697910Johnell O. The socioeconomic burden of fractures: today and in the 21st century. Am J Med. 1997 Aug 18;103(2A):20S-25S; discussion 25S-26S. doi: 10.1016/s0002-9343(97)90023-1.
PubMed 9302894Leal J, Gray AM, Prieto-Alhambra D, Arden NK, Cooper C, Javaid MK, Judge A; REFReSH study group. Impact of hip fracture on hospital care costs: a population-based study. Osteoporos Int. 2016 Feb;27(2):549-58. doi: 10.1007/s00198-015-3277-9. Epub 2015 Aug 19.
PubMed 26286626Heiden JJ, Goodin SR, Mormino MA, Siebler JC, Putnam SM, Lyden ER, Tao MA. Early Ambulation After Hip Fracture Surgery Is Associated With Decreased 30-Day Mortality. J Am Acad Orthop Surg. 2021 Mar 1;29(5):e238-e242. doi: 10.5435/JAAOS-D-20-00554.
PubMed 32694326Kuru T, Olcar HA. Effects of early mobilization and weight bearing on postoperative walking ability and pain in geriatric patients operated due to hip fracture: a retrospective analysis. Turk J Med Sci. 2020 Feb 13;50(1):117-125. doi: 10.3906/sag-1906-57.
PubMed 31742370
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Rate of Early Mobilisation in Hip Fracture Patients Using Alfentanil Better Than Standard Opioid Analgesia (REHAB): a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06212622
- Acronym / sponsor ID
- REHAB / AC23143
- Conditions
- Hip Injuries, Hip Fractures, Pain, Post Operative Pain, Early Ambulation
- Keywords
- early mobilisation, hip fracture, pain, oxycodone, alfentanil, ambulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hip fracture injuries are linked with increased morbidity, frailty, and mortality risk. Studies have shown that in hip fracture surgery, early mobilisation confers better pain control, 30-day complication and mortality rates and could reduce in hospital length of stay.
Though early mobilisation may provide numerous post operative benefits, there are barriers to achieving this reliably and effectively. One such difficulty is pain.
In the Royal Infirmary of Edinburgh (RIE) like many boards across Scotland, oral oxycodone has been routinely used as analgesia to help with post operative pain, in patients who have undergone orthopaedic trauma injuries. However, this analgesic modality is utilised to help with general post operative pain, rather than targeted abolition of pain prior to physiotherapy.
Alfentanil is a relatively new medication which has a very rapid onset of action and short half life. Alfentanil may prove to be a superior form of analgesia for the purpose of encouraging early mobilisation after hip fracture surgery. This study could provide robust evidence for regular use of alfentanil prior to physiotherapy in early post operative hip fracture surgery patients.
Detailed description
Hip fractures are amongst the most common orthopaedic injuries. These fractures predominantly occur in the elderly population, secondary to osteoporosis. Projection studies from across the world suggest that incidence rates of hip fractures are set to increase. Worldwide projections indicate that hip fracture cases will double from 1.26 million in 1990, to 2.6 million by 2025, and to 4.5 million by 2050. The National Joint Registry reports that the number of hip fractures have increased from 1,371 in 2010 to 84,998 in 2021 across England, Wales and Northern Ireland. The Scottish Hip Fracture Audit identifies an increase from 6,369 hip fracture cases in 2007 to 8,380 in 2022. Given the exponential rise in the frail elderly population, these numbers will only further rise in the future.
Hip fracture injuries are linked with increased morbidity, frailty, and mortality risk. Moreover, there is significant social and economic costs on the healthcare system stemming from these injuries. In the United States, these costs are greater than $5.96 billion, annually. In the United Kingdom, these costs are approximately £1.1 billion. Healthcare systems globally, are becoming progressively more financially restrained, and the incidence of hip fractures are set to increase. Thus, further emphasis should be placed on interventions to reduce morbidity and mortality in this frail elderly patient group.
Many studies have shown that early mobilisation after hip fracture surgery provides reduced post operative pain and complication rates and reduces length of stay (LOS) in hospital. Some studies have demonstrated that early ambulation reduces 30-day mortality rates in this patient population. It has been demonstrated that early mobilisation was also associated with an increased rate of discharges directly home, compared to those patients who mobilised late. Although elderly patients have associated co-morbidity and a higher risk of delirium, neither factors influenced inability to mobilise early after surgery. They also found that a greater number of patients who mobilised early were able to be discharged directly home.
Though early mobilisation may provide numerous post operative benefits, there are barriers to achieving this reliably and effectively. One such difficulty is pain. Studies report that pain is often a key obstacle to early ambulation after surgery. In the Royal Infirmary of Edinburgh (RIE) like many boards across Scotland, oral oxycodone has been routinely used as analgesia to help with post operative pain, in patients who have undergone orthopaedic trauma injuries. However, this analgesic modality is utilised to help with general post operative pain, rather than targeted abolition of pain prior to physiotherapy.
Oxycodone has been utilised in clinical practice since 1917. There is in depth literature on the pharmacokinetics of oxycodone. The onset of action of oral oxycodone is between 10-30 minutes. Peak onset occurs around 1 hour. Plasma half-life is 3-5 hours, regardless of route of administration.
On the other hand, alfentanil is relatively new, and the literature is scarce on its pharmacokinetic properties. There is consensus amongst the literature that onset of action of alfentanil is very rapid, with peak onset of intravenous alfentanil as quick as 2 minutes. Plasma half-life of oral alfentanil is 1-2 hours. Moreover, side effects of respiratory depression are lower than that from fentanyl or sufentanil. The combination of rapid onset of pain relief, with an equally quick excretion, makes this medication appealing in palliative care medicine, in which patients are typically frail. This is particularly the case in patients with renal impairment since this medication is excreted by the liver.
Alfentanil may prove to be a superior form of analgesia for the purpose of encouraging early mobilisation after hip fracture surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STANDARD CARE WITH ORAL OXYCODONE | – | Drug: OxycodoneThese patients will receive oral oxycodone prior to their post operative day 1 and 2 physiotherapy sessions The dose is age dependent (and also on frailty status): < 65 years old: Oxycodone 5mg immediate release 65 - 85 years old: Oxycodone 4mg immediate release > 85 years old: Oxycodone 3mg immediate release <50kg or particularly frail: Oxycodone 2mg immediate release |
| INTERVENTION GROUP WITH SUBCUTANEOUS ALFENTANIL | – | Drug: AlfentanilThese patients will receive subcutaneous alfentanil prior to their post operative day 1 and 2 physiotherapy sessions This is 100 micrograms as a subcutaneous injection |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants listed for urgent hip fracture surgery, after sustaining a hip fracture surgery under the care of participating surgeons at the institution of RIE. 64 participants will be included in this prospective cohort study, 32 in each cohort. There will be consecutively recruitment and follow all hip fracture patients admitted over a month at RIE.
Key inclusion criteria (4 listed)
- Listed for urgent hip fracture surgery - dynamic hip screw/cannulated hip screw/hemiarthroplasty/total hip arthroplasty/intramedullary nail
- Sustained an insufficiency/low energy type hip fracture
- Male or female aged over 60
- Able to provide informed consent
Key exclusion criteria (8 listed)
- Pathological or periprosthetic hip fracture
- Mechanism of injury for hip fracture was of high energy
- Patient is unable to comply with the study protocol or functional assessments
- Patients aged less than 60
- Patients who were wheelchair bound prior to injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlfentanilSubcutaneous injection | Drug | INTERVENTION GROUP WITH SUBCUTANEOUS ALFENTANIL |
| OxycodoneOral solution | Drug | STANDARD CARE WITH ORAL OXYCODONE |
Primary outcome
Visual analogue scale score
Time frame: On post operative day 1
Pain assessment using the visual analogue scale. This is a visual scale measured from 0 to 10, where 0 is no pain and 10 is very severe pain.
Ability to mobilise
Time frame: On post operative day 1
Ability to mobilise based on pre assigned physiotherapy levels (PT): * PT level 1 -> standing transfer: ability to weight bear on both legs, and transferring from bed to chair without stepping. Equipment will be utilised to help the patient swing round from bed to chair (sara steady/sam hall turner) * PT level 2 -> stepping transfer: ability to weight bear on both legs, and transferring from bed to chair with stepping. Equipment will be utilised to help support the patient when stepping (gutter frame/Zimmer frame) * PT level 3A -> mobilising to the toilet with assistance of two people * PT level 3B -> mobilising to the toilet with assistance of one person * PT level 3C -> mobilising to the toilet without assistance
7 secondary outcomes
Visual analogue scale score
Time frame: On post operative day 2
Ability to mobilise
Time frame: On post operative day 2
EuroQol five dimension (EQ-5D) - 5L patient reported outcome measure
Time frame: At post operative day (POD) 1, POD2, POD 7 and POD 30
In hospital length of stay
Time frame: From date of admission until the date of discharge from hospital or date of death, whichever came first (assessed up to 52 weeks)
Total use of analgesia over post operative day 1 and post operative day 2
Time frame: post operative day 1 and post operative day 2
Complication rates and 30-day mortality
Time frame: At post operative day (POD) 1, POD2, POD 7 and POD 30
Discharge destination
Time frame: Pre admission location will be assessed on the date of admission. Discharge destination will be sought, on the date of discharge from hospital (assessed up to 52 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 8093403Cummings SR, Black DM, Nevitt MC, Browner W, Cauley J, Ensrud K, Genant HK, Palermo L, Scott J, Vogt TM. Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group. Lancet. 1993 Jan 9;341(8837):72-5. doi: 10.1016/0140-6736(93)92555-8.
- BackgroundKazley J, Bagchi K. Femoral Neck Fractures. StatPearls [Internet]. 2023 May 8 [cited 2023 Sep 1]; Available from: https://www.ncbi.nlm.nih.gov/books/NBK537347/
- BackgroundBrittain R, Howard P, Lawrence S, Stonadge J, Wilkinson M, Wilton T, et al. NJR statistical analysis, support and associated services National Joint Registry | 19th Annual Report. [cited 2023 Sep 1]; Available from: www.njrcentre.org.uk
- BackgroundHealth Scotland P. Scottish Hip Fracture Audit Report 2023 Reporting on episodes of hip fractures in 2022 A Management Information release for Scotland
- BackgroundScottish Hip Fracture Audit Report 2008 Contents. 2006 [cited 2023 Sep 1]; Available from: www.shfa.scot.nhs.uk
- Background: PubMed 30174210Kingston A, Comas-Herrera A, Jagger C; MODEM project. Forecasting the care needs of the older population in England over the next 20 years: estimates from the Population Ageing and Care Simulation (PACSim) modelling study. Lancet Public Health. 2018 Sep;3(9):e447-e455. doi: 10.1016/S2468-2667(18)30118-X. Epub 2018 Aug 31.
- Background: PubMed 30918799Downey C, Kelly M, Quinlan JF. Changing trends in the mortality rate at 1-year post hip fracture - a systematic review. World J Orthop. 2019 Mar 18;10(3):166-175. doi: 10.5312/wjo.v10.i3.166. eCollection 2019 Mar 18.
- Background: PubMed 15095097Gdalevich M, Cohen D, Yosef D, Tauber C. Morbidity and mortality after hip fracture: the impact of operative delay. Arch Orthop Trauma Surg. 2004 Jun;124(5):334-40. doi: 10.1007/s00402-004-0662-9. Epub 2004 Apr 17.
- Background: PubMed 23569656Schnell S, Friedman SM, Mendelson DA, Bingham KW, Kates SL. The 1-year mortality of patients treated in a hip fracture program for elders. Geriatr Orthop Surg Rehabil. 2010 Sep;1(1):6-14. doi: 10.1177/2151458510378105.
- Background: PubMed 31161153Adeyemi A, Delhougne G. Incidence and Economic Burden of Intertrochanteric Fracture: A Medicare Claims Database Analysis. JB JS Open Access. 2019 Feb 27;4(1):e0045. doi: 10.2106/JBJS.OA.18.00045. eCollection 2019 Mar 27.
- Background: PubMed 12697910Christodoulou C, Cooper C. What is osteoporosis? Postgrad Med J. 2003 Mar;79(929):133-8. doi: 10.1136/pmj.79.929.133.
- Background: PubMed 9302894Johnell O. The socioeconomic burden of fractures: today and in the 21st century. Am J Med. 1997 Aug 18;103(2A):20S-25S; discussion 25S-26S. doi: 10.1016/s0002-9343(97)90023-1.
- Individual participant dataSharing planned: No
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SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Clement, MBBS, MD, PhD, FRCS (T&O) principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Injuries and Hip Fractures, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale score (time frame: On post operative day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06212622, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.