Does Rapid Mobilisation Improve Length of Stay and Outcomes Post THR

NCT02428829 | Completed

• 1 other identifier: RAPID-1
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arthroplasty, Replacement, Hip; Hip Replacement, Total

Keywords

hip; replacement; arthroplasty; total; orthopaedic; rehabiliation; physiotherapy; therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (4)

• Patient satisfaction with physiotherapy care following completion of physiotherapy care as measured by completion of patient satisfaction questionnaire results

  12 weeks

• Time taken for patients to reach functional milestones postoperatively

  4 hours

• The incidence rate of postoperative complications

  12 weeks

• Numerical pain scores for the patients postoperative pain

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group will be seen by a physiotherapist to attempt walking from 4 hours post operatively, on the day of their surgery.

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

Procedure: Control - standard treatment

Interventions

Attempt walking from 4 hours post operatively, on the day of their surgery. PROCEDURE

Intervention group will be seen by a physiotherapist to attempt walking from 4 hours post operatively, on the day of their surgery.

Intervention

Control - standard treatment PROCEDURE

standard physiotherapy in line with current hospital protocol including first walking approximately 24 hours post operatively.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Fully Weight Bearing
• Weight Bearing as Tolerated.
• Adequate home support to facilitate timely discharge.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead

Study Sites (1)

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Study Officials

• Christopher Efford, BSc(Hons)

  Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

GB (1)