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Hip FractureHemiSPAIRENCT04095611

A Modified Muscle Sparing Posterior Technique (SPAIRE) in Hip Hemiarthroplasty for Displaced Intracapsular Fractures.

A study testing SPAIRE and LATERAL in people with Hip Fracture, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Which technique is best for partial hip replacement? Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hip Fracture
What is being tested?
SPAIRE and LATERAL
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
1 siteUnited Kingdom
Study dates
25 Nov 2019to 19 Aug 2022
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 60+ presenting with an intracapsular hip fractures requiring cemented hip hemiarthroplasty (NICE CG124 2011), and who are resident in the South West of England

Who cannot join

  • Patients that were immobile (unable to walk) before the hip fracture occurred.
  • Patients that are not expected to live until post operative day 120 due to chronic illness and are receiving surgery for palliative care.
  • Use of femoral stems that are not of a proven stem design, in line with the recommendations set by the NICE clinical guideline on hip fracture management (NICE CG124 2011).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Royal Devon and Exeter NHS Trust

    Exeter, Devon, EX25DW

Other trials in United Kingdom

About this study

Official title: The Effects of a Modified Muscle Sparing Posterior Technique (SPAIRE) in Hip Hemiarthroplasty for Displaced Intracapsular Fractures on Post-operative Function Compared to a Standard Lateral Approach; a Randomised Controlled Trial

Which technique is best for partial hip replacement?

Read the detailed description

Aim of study: To compare two ways of performing partial hip replacement to see which one allows patients to mobilise better and gives patients improved function after surgery. The best approach is more likely to allow patients to maintain their independence and return to their own homes after their injury.

Background: When someone breaks their hip they often need a partial hip replacement, also known as hemiarthroplasty. To perform this operation surgeons need to cut through some muscles to expose the hip joint and perform the partial replacement. Currently, clinical guidelines suggest that this operation should be performed using a technique which involves cutting muscles and tendons from the side of the hip. This is called the lateral approach. Alternatively, a newer, modified technique can be used leaving all the major muscles intact and this may cause fewer problems for the patient. There is no research evidence to prove which approach is more beneficial. Patients and carers looking for information about this are likely to become confused by the many opinions of surgeons speaking about preferred techniques. It is therefore important to find out which technique is better for patients, based on research rather than opinion.

Study design: We will randomly allocate patients who agree to be part of the study to have one of the two techniques to partial hip replacement. We can then compare the impact of the two techniques on how well and fully patients mobilise, the level of pain they experience, and the safety of the techniques. We will also contact a number of patients from both treatment groups to discuss their experience of the surgery in more detail.

Patient and public involvement: This study was inspired by patients who said that mobility and speed to regaining independence are the most important outcomes after surgery. Patients and carers will continue to be involved throughout this study, to ensure that the study results are relevant and important to people at risk of breaking their hip.

Dissemination: We will publish the results of this study widely in scientific and other publications accessable to patients and all involved in the treatment of patients with hip fractures. We will work with surgeons, carers and patients to ensure all appropriate networks are aware of the results and that the outcomes are disseminated in an accessible way so that practices can be changed based on the results of this study.

Conditions
Hip Fracture
Being tested
SPAIRE, LATERAL
Keywords
Hemiarthroplasty, Hip fracture, Modified Muscle Sparing Posterior Technique (SPAIRE), Displaced Intracapsular Hip Fracture
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPAIREProcedure or surgery

    To perform the hip surgery called hemiarthroplasty surgeons need to cut through some muscles to expose the hip joint and perform the partial replacement. Currently this often performed using a technique which involves cutting muscles and tendons from the side of the hip and this is called the lateral approach. SPAIRE is a modified technique that accesses the surgical area through a different route.

  • LATERALProcedure or surgery

    surgery in adults with a displaced intracapsular hip fracture requiring hemiarthroplasty, the standard lateral approach.

Study groups in NCT04095611
Study groupRoleWhat they receive
SPAIREExperimentalhemiarthroplasty surgery, the muscle-sparing modification of the posterior approach (SPAIRE).
Receives: Procedure: SPAIRE
LATERALActive comparatorhemiarthroplasty surgery, the standard lateral approach
Receives: Procedure: LATERAL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxford Hip Score (OHS)

    The Oxford Hip Score is a short patient-reported measure of function and pain following hip surgery (Dawson 1996).

    OHS Range: 0-48, with higher scores representing a better outcome

    Measured: Post operative day 120

Secondary outcomes (15)
  1. De Morton Mobility Index (DEMMI)

    The De Morton Mobility Index (DEMMI) assessment tool is a functional test that has been validated for acute hip fracture patient rehabilitation (De Morton 2013) and can be used in the early and late post-operative phases. In particular, it measures patient mobility with no reported ceiling effect. It is completed by a research nurse; hence cognitive impairment of the patient need not prevent its use.

    Raw Score Scale: 0-19 DEMMI Score Scale: 0-100 With higher scores indicating a better outcome

    Measured: Post operative day 3 and 120

  2. Cumulated Ambulation Score (CAS)

    The Cumulated Ambulation Score (CAS) is a simple functional tool where patients are assessed daily on their ambulatory capacity by the treating rehabilitation team during the first three post-operative days, having been validated for use with acute hip fracture rehabilitation (Foss et al. 2006) and is intended to be used in the early rehabilitation phase, being applicable to patients of all cognitive levels. It will serve as a secondary outcome of which criteria are readily available in patients' records and will ensure no potential floor effect of evaluation from the DEMMI score.

    CAS Score Scale Range: 0-18, with higher scores indicating better outcomes

    Measured: Post operative day 3

  3. Oxford Hip Score (OHS)

    The Oxford Hip Score is a short patient-reported measure of function and pain following hip surgery (Dawson 1996).

    OHS Range: 0-48, with higher scores representing a better outcome

    Measured: Post operative day 3

  4. Standardised instrument for measuring generic health status: European Quality of Life 5 Dimensions, 5 Levels (EQ-5D-5L)

    A generic utility index capturing 5 dimensions of health-related quality of life (Herdman 2011) 5 dimensions indicating QoL with each dimension scored in a range from 1-5 with higher scores indicating a worse outcome. The scores for each dimension are listed together to indicate a health state, for example '12345'.

    Overall health scale range:0-100 with higher indicating better health

    EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, may be converted into a single index value. Please see website for details.

    Measured: Post operative day 3 and 120

  5. Numeric pain Rating Scale (NRS)

    Numeric pain Rating Scale (NRS) Participants are asked to indicate their pain in the last 24 hours on a scale from 0-10, with higher scores indicating more pain.

    For details see:

    Dworkin, R. H., Turk, D. C., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Katz, N. P., ... \& Carr, D. B. (2005). Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain, 113(1), 9-19.

    Measured: Post operative day 3 and 120

  6. Analgesia medications used by participants

    Analgesia medication use will be recorded from patient medical notes, with a tick to indicate which (if any) of the following medications are being taken.

    Medications:

    Paracetamol / codeine / ibuprofen or other non-steroidal anti-inflammatory drug (NSAID) / tramadol / morphine / oxycodone / or other

    Measured: Post operative day 3 and 120

  7. Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded

    AE will be recorded, defined as any negative consequence of care that results in unintended injury or illness that may or may not have been preventable. For example:

    A physical event, A psychological event (e.g., depressed mood). A laboratory event (e.g., elevated blood sugar). An increase in the severity/frequency of a pre-existing symptom or condition

    An AE is considered serious if it poses a threat to the patient's life or functioning.The FDA defines a SAE as any untoward medical occurrence that:

    Results in death, or Is life-threatening (places the patient at risk of death), or Requires or prolongs an existing hospitalization, or Causes persistent or significant disability or incapacity, or Is a birth defect, or Requires medical intervention to prevent one of the above outcomes

    These will include records of surgical complications: categorized as dislocation, nerve injury, vascular injury, periprosthetic fracture, infection, need for re-operation (with reasons).

    Measured: Throughout study participation, on average 120 days

  8. Length of stay in hospital (acute and super-spell)

    Length of stay in hospital for the acute hospital admission time will be recorded as number of days in hospital. Likely to be between 4 and 10 days. Length of stay will also be recorded for the total Trust stay (super-spell) that includes any time spent at rehabilitation units.

    Measured: Recorded on day of discharge (likely day 4-10 post operation) and through study completion, on average 120 days

  9. Place of residence

    Participant's place of residence, recorded as:

    • own home,
    • residential/supported living,
    • nursing home or
    • other. These data will be collected from clinical notes to capture location pre-fracture. It will be collected from patient notes indicating the discharge destination, and will be collected at post operative day (POD) 120.

    Measured: At 3 time points (pre-fracture, on hospital discharge and at POD120). Throughout study participation, on average 120 days

  10. American Society of Anaesthesiologists (ASA) Physical Status Classification

    The ASA measure of physical status of the patient at the time of the operation will be recorded from surgical notes.

    Scale 1-5, with higher indicating worse health status

    Measured: Day of operation

  11. Qualitative interviews with participants

    We will conduct up to 20 semi-structured telephone interviews with patients (10 in each arm) to examine their experience of the impact of surgery and recovery period, including factors such as pain, mobility, function, independence and quality of life. Participants will be sampled from across the hospital sites taking part in the trial. The patient and public involvement group will advise on the design of the interview schedule.

    Interviews will be conducted at POD120

    Measured: Post operative day 120

  12. Patient date of birth

    Date of birth will be sourced via patient records and checked with patient at POD 3.

    Measured: Post operative day 3

  13. Patient gender

    Gender will be sourced via patient records and checked with patient at POD 3.

    Measured: Post operative day 3

  14. Patient ethnicity

    Patient (or consultee if patient cognitively impaired) will be asked to indicate patient ethnicity at POD 3.

    Measured: Post operative day 3

  15. Cognition as assessed by surgical team

    Patient level of cognition - (impaired or not impaired) will be obtained from the operation notes.

    Before the operation the surgical team make a clinically informed decision about whether the patient is able to consent to the operation themselves (not impaired) or lacks capacity (impaired) and will need a consultee to consent to surgery on their behalf. The outcome of this assessment (which is derived using the Abbreviated Mental Test (AMT)) is detailed in the patient's medical notes. A broad categorisation of 'impaired' (if patient required a consultee to consent to surgery) or not impaired (if patient was able to consent to surgery themselves) will be derived from the patient's medical notes, and recorded for this study.

    Measured: Day of operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start25 Nov 2019
  3. Primary completion19 Aug 2022
  4. Study completion19 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04095611
Sponsor's protocol ID
IRAS: 258327
Acronym
HemiSPAIRE
Status last verified
Jan 2024
First submitted
22 Jul 2019
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Price A, Ball S, Rhodes S, Wickins R, Gordon E, Aylward A, Cockcroft E, Morgan-Trimmer S, Powell R, Timperley J, Charity J. Effects of a modified muscle sparing posterior technique in hip hemiarthroplasty for displaced intracapsular fractures on postoperative function compared to a standard lateral approach (HemiSPAIRE): protocol for a randomised controlled trial. BMJ Open. 2021 Jun 8;11(6):e045652. doi: 10.1136/bmjopen-2020-045652.

    PubMed 34103316
  • Ball S, McAndrew A, Aylward A, Cockcroft E, Gordon E, Kerridge A, Morgan-Trimmer S, Powell R, Price A, Rhodes S, Timperley AJ, van Horik J, Wickins R, Charity J. Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE. Trials. 2022 Nov 5;23(1):924. doi: 10.1186/s13063-022-06790-z.

    PubMed 36335403
  • Ball S, Aylward A, Cockcroft E, Corr A, Gordon E, Kerridge A, McAndrew A, Morgan-Trimmer S, Powell R, Price A, Rhodes S, Timperley AJ, van Horik J, Wickins R, Charity J. Clinical effectiveness of a modified muscle sparing posterior technique compared with a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicenter, parallel-group, randomized controlled trial. BMJ Surg Interv Health Technol. 2024 Jun 17;6(1):e000251. doi: 10.1136/bmjsit-2023-000251. eCollection 2024.

    PubMed 38895600

Questions about this trial

What is this clinical trial studying?

A study testing SPAIRE and LATERAL in people with Hip Fracture, run by Royal Devon and Exeter NHS Foundation Trust 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 1 inclusion and 3 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 11 Jan 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?

Oxford Hip Score (OHS) (time frame: Post operative day 120). 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 NCT04095611, which also lists 3 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 11 Jan 2024.

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