Arthroplasty, Replacement, HipRAPIDNCT02428829
Does Rapid Mobilisation Improve Length of Stay and Outcomes Post THR
A study testing Attempt walking from 4 hours post operatively, on the day of their surgery. in people with Arthroplasty, Replacement, Hip and Hip Replacement, Total, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
Trial summary
This study looks to examine the effect of attempting initial postoperative walking with a patient following a total hip replacement. Currently patients rest in bed for approximately 24 hours following their operation before walking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Hip Replacement, Total
- What is being tested?
- Attempt walking from 4 hours post operatively, on the day of their surgery.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed written consent
- Able to understand verbal and written communication in English
- Over 18 years of age
- Primary Uni-lateral Total Hip Replacement (THR)
- No intra-operative complications
- Weight bearing status:
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- Fully Weight Bearing
- Weight Bearing as Tolerated.
- Adequate home support to facilitate timely discharge.
Who cannot join
- No current or historical serious co-morbidities:
- Cerebro-Vascular Accident (CVA)
- Myocardial Infarction (MI)
- Pulmonary Embolism (PE)
- Deep Vein Thrombosis (DVT) o Diabetes Mellitus (DM)
- Significant intra or post-operative wound ooze
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- Poor pre-morbid mobility/level of function (House or wheelchair bound)
- Clinical signs of DVT or PE
- Altered Weight-Bearing status
- Repair to abductor muscle complex
- Nerve block as part of anaesthetic
- Participation in any other research trials
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW
About this study
Official title: Does Rapid Mobilisation as Part of an Enhanced Recovery Pathway Improve Length of Stay, Return to Function and Patient Satisfaction Post Primary Total Hip Arthroplasty?
This study looks to examine the effect of attempting initial postoperative walking with a patient following a total hip replacement. Currently patients rest in bed for approximately 24 hours following their operation before walking. The intervention group would aim to commence walking at between 4-6 hours after their operation.
Outcome measures to be examined would be: length of hospital stay, patient experience of physiotherapy treatment, the time taken for patients to reach functional milestones and number of postoperative medical complications.
The study is designed as a randomised controlled trial where participants would be separated randomly into two groups. One group would form the intervention group and start physiotherapy and attempted walking 4-6 hours after their operation. The other group would form the control group and would remain on the current standard rehabilitation protocol.
Read the detailed description
As part of this study, patients who are waiting for a total hip replacement, and have no other serious medical problems will be given an information sheet about the study at the preoperative education group session approximately 12 weeks prior to their surgery. If they are interested they would be asked on the day of their operation if they would like to take part in the study, potential participants will have had the opportunity to ask any questions to a senior member of the research team over the telephone or at a further study specific appointment if they wish before this stage.
Any patients who agree to take part would be free to withdraw from the study at any time, without any implications for their ongoing medical treatment. Patients do not have to give a reason as to why they would like to stop taking part, this is explained during the consent process but will be reiterated to participants during the study.
Once participants have entered the study, they would be selected at random to one of two groups:
Group 1: (Rapid Mobilisation Group) Participants will be seen between 4 and 6 hours after returning to the ward after surgery. The physiotherapist would aim to start walking with them at this stage, as long as the physiotherapist feels that this is safe.
Group 2: (Control Group) Participants will be seen between 4 and 6 hours after returning to the ward after surgery. The physiotherapist would start exercises on the bed with these patients. This is standard practice and is the current patient protocol at the Royal Bournemouth Hospital. The rest of their stay as a patient would continue as normal in accordance with standard care.
The following items will be measured for each patient:
- How long they stay in hospital after their operation
- How satisfied they were with physiotherapy.
- Their pain levels when walking for the first time.
- How quickly they return to independence with walking and other tasks.
- Whether they had any medical complications after their operation.
The null hypothesis is that rapid walking following total hip replacement does not affect the amount of time patients stay in hospital, the amount of time taken to reach functional milestones such as walking or stairs, and how the patient grades their experience of physiotherapy.
The results of this research would then be analysed both at half way through data collection and at the end of data collection by the research team and the Sponsor and would be published as part of a research paper in a medical journal. This type of study design has been chosen to provide the research team with a high quality comparison between the two groups. Due to the nature of the treatment it was felt that it wasn't possible to implement any participant or clinician blinding to the methodology.
However, both groups of patients will be treated using a treatment protocol to limit any differences between group interventions.
- Being tested
- Attempt walking from 4 hours post operatively, on the day of their surgery., Control - standard treatment
- Keywords
- hip, replacement, arthroplasty, total, orthopaedic, rehabiliation, physiotherapy, therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attempt walking from 4 hours post operatively, on the day of their surgery.Procedure or surgery
Intervention group will be seen by a physiotherapist to attempt walking from 4 hours post operatively, on the day of their surgery.
Control - standard treatmentProcedure or surgery
standard physiotherapy in line with current hospital protocol including first walking approximately 24 hours post operatively.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group will be seen by a physiotherapist to attempt walking from 4 hours post operatively, on the day of their surgery. Receives: Procedure: Attempt walking from 4 hours post operatively, on the day of their surgery. |
| Control | Active comparator | Control group will receive standard physiotherapy in line with current hospital protocol including first walking approximately 24 hours post operatively Receives: Procedure: Control - standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of inpatient hospital stay following return to the ward after total hip replacement
This is measured in number of days. The study would determine a change in length of stay by one day clinically significant.
Measured: 7 days
Secondary outcomes (4)
Patient satisfaction with physiotherapy care following completion of physiotherapy care as measured by completion of patient satisfaction questionnaire results
No significant differences between the groups or better would be considered clinically significant
Measured: 12 weeks
Time taken for patients to reach functional milestones postoperatively
An average reduction of greater than or equal to 4 hours would be considered clinically significant
Measured: 4 hours
The incidence rate of postoperative complications
No significant differences between the groups or better would be considered clinically significant
Measured: 12 weeks
Numerical pain scores for the patients postoperative pain
No significant differences between the groups or better would be considered clinically significant
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Efford, BSc(Hons), Principal investigator, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428829
- Sponsor's protocol ID
- RAPID-1
- Acronym
- RAPID
- Status last verified
- Jan 2020
- First submitted
- 21 Apr 2015
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Rapid Mobilisation as Part of an Enhanced Recovery Pathway Improve Length of Stay, Return to Function and Patient Satisfaction Post Primary Total Hip Arthroplasty?
- ClinicalTrials.gov ID
- NCT02428829
- Acronym / sponsor ID
- RAPID / RAPID-1
- Keywords
- hip, replacement, arthroplasty, total, orthopaedic, rehabiliation, physiotherapy, therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 29 Apr 2015 (estimated)
- 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.
This study looks to examine the effect of attempting initial postoperative walking with a patient following a total hip replacement. Currently patients rest in bed for approximately 24 hours following their operation before walking. The intervention group would aim to commence walking at between 4-6 hours after their operation.
Outcome measures to be examined would be: length of hospital stay, patient experience of physiotherapy treatment, the time taken for patients to reach functional milestones and number of postoperative medical complications.
The study is designed as a randomised controlled trial where participants would be separated randomly into two groups. One group would form the intervention group and start physiotherapy and attempted walking 4-6 hours after their operation. The other group would form the control group and would remain on the current standard rehabilitation protocol.
Detailed description
As part of this study, patients who are waiting for a total hip replacement, and have no other serious medical problems will be given an information sheet about the study at the preoperative education group session approximately 12 weeks prior to their surgery. If they are interested they would be asked on the day of their operation if they would like to take part in the study, potential participants will have had the opportunity to ask any questions to a senior member of the research team over the telephone or at a further study specific appointment if they wish before this stage.
Any patients who agree to take part would be free to withdraw from the study at any time, without any implications for their ongoing medical treatment. Patients do not have to give a reason as to why they would like to stop taking part, this is explained during the consent process but will be reiterated to participants during the study.
Once participants have entered the study, they would be selected at random to one of two groups:
Group 1: (Rapid Mobilisation Group) Participants will be seen between 4 and 6 hours after returning to the ward after surgery. The physiotherapist would aim to start walking with them at this stage, as long as the physiotherapist feels that this is safe.
Group 2: (Control Group) Participants will be seen between 4 and 6 hours after returning to the ward after surgery. The physiotherapist would start exercises on the bed with these patients. This is standard practice and is the current patient protocol at the Royal Bournemouth Hospital. The rest of their stay as a patient would continue as normal in accordance with standard care.
The following items will be measured for each patient:
- How long they stay in hospital after their operation
- How satisfied they were with physiotherapy.
- Their pain levels when walking for the first time.
- How quickly they return to independence with walking and other tasks.
- Whether they had any medical complications after their operation.
The null hypothesis is that rapid walking following total hip replacement does not affect the amount of time patients stay in hospital, the amount of time taken to reach functional milestones such as walking or stairs, and how the patient grades their experience of physiotherapy.
The results of this research would then be analysed both at half way through data collection and at the end of data collection by the research team and the Sponsor and would be published as part of a research paper in a medical journal. This type of study design has been chosen to provide the research team with a high quality comparison between the two groups. Due to the nature of the treatment it was felt that it wasn't possible to implement any participant or clinician blinding to the methodology.
However, both groups of patients will be treated using a treatment protocol to limit any differences between group interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Attempt walking from 4 hours post operatively, on the day of their surgery.Intervention group will be seen by a physiotherapist to attempt walking from 4 hours post operatively, on the day of their surgery. |
| Control | Active comparator | Procedure: Control - standard treatmentControl group will receive standard physiotherapy in line with current hospital protocol including first walking approximately 24 hours post operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to give informed written consent
- Able to understand verbal and written communication in English
- Over 18 years of age
- Primary Uni-lateral Total Hip Replacement (THR)
- No intra-operative complications
Key exclusion criteria (12 listed)
- No current or historical serious co-morbidities:
- Cerebro-Vascular Accident (CVA)
- Myocardial Infarction (MI)
- Pulmonary Embolism (PE)
- Deep Vein Thrombosis (DVT) o Diabetes Mellitus (DM)
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 |
|---|---|---|
| Attempt walking from 4 hours post operatively, on the day of their surgery.Intervention group will be seen by a physiotherapist to attempt walking from 4 hours post operatively, on the day of their surgery. | Procedure or surgery | Intervention |
| Control - standard treatmentstandard physiotherapy in line with current hospital protocol including first walking approximately 24 hours post operatively. | Procedure or surgery | Control |
Primary outcome
Length of inpatient hospital stay following return to the ward after total hip replacement
Time frame: 7 days
This is measured in number of days. The study would determine a change in length of stay by one day clinically significant.
4 secondary outcomes
Patient satisfaction with physiotherapy care following completion of physiotherapy care as measured by completion of patient satisfaction questionnaire results
Time frame: 12 weeks
Time taken for patients to reach functional milestones postoperatively
Time frame: 4 hours
The incidence rate of postoperative complications
Time frame: 12 weeks
Numerical pain scores for the patients postoperative pain
Time frame: 12 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 29 Jan 2020.
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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.
Christopher Efford, BSc(Hons) principal investigator
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attempt walking from 4 hours post operatively, on the day of their surgery. in people with Arthroplasty, Replacement, Hip and Hip Replacement, Total, run by The Royal Bournemouth Hospital 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 9 inclusion and 12 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 29 Jan 2020. 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?
Length of inpatient hospital stay following return to the ward after total hip replacement (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2020.