Unrestricted Rehabilitation Pathway Following Total Hip Replacement (ReHip2)

November 14, 2022 updated by: Justine Theaker, University of Manchester

A Randomised Controlled Trial of the Impact on Function of an Unrestricted Rehabilitation Pathway of no Precautions Following Total Hip Replacement

The purpose of ReHip2 is to explore the impact on function and quality of life in patients following Total Hip Replacement (THR). A randomised controlled trial will compare two different rehabilitation pathways following surgery (Routine care with precautions and Treatment group with no precautions). The proposal is to carry out the RCT with a minimum of 182 patients based in the UK.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Dislocation of the hip following total hip replacement (THR) is the sole reason for the endorsement of precautions following THR. This has remained unchanged sine the first hip replacement in 1969.

The precautions are;

  • Patients must not bend past 90 degrees at the hip (including sitting)
  • Patients must not twist in either standing or sitting
  • Patients must partial weight bear with elbow crutches for a minimum of 6 weeks
  • Patients must sleep on their back for a minimum of 6 weeks
  • Patients must not cross their legs

Studies exploring factors affecting dislocation following THR identified three main influences: surgical technique, type of prosthesis and post-operative precautions. A number of studies have challenged the continued use of precautions or explored their impact on dislocation. However, these studies did not fully consider the impact of all precautions on dislocation, choosing to only select elements of the precautions for investigation. A recent review concluded the evidence evaluating practice and the impact of precautions was of poor quality. The review suggested further research should take into account different surgical approaches, different femoral head sizes and the type of prosthesis. Although there are studies that explored some of these hip dislocation confounders, the true impact of precautions remains unknown.

Whilst precautions continue to be endorsed by surgeons and other clinicians, previous challenges have raised awareness of the possible excessiveness of precautions and the importance of further robust work recommended. This is particularly so in the wake of developments in surgical technique and prostheses design, such as hip joint capsule repair and larger femoral head sizes (larger hip replacements). These developments and their impact on dislocation are beginning to cast doubt on the impact of post-operative precautions and their direct link to incidence of dislocation, which is their primary purpose.

The imposition of precautions has been evidenced to impact on both function and quality of life, with resultant non adherence in a proportion of patients. This study intends to explore whether an unrestricted pathway has no worse outcome in function, pain and quality of life parameters, in two specialist units in a multi-centre, prospective, randomised, non-inferiority study.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust
      • Wigan, United Kingdom, WN6 9EP
        • Wrightington Wigan and Leigh NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult participants over the age of 18 years will be included.
  • All participants should be proceeding with routine care unilateral (one side only) primary THR for treatment of osteoarthritis
  • The patients operating consultant agreed to involvement of their patients in the study.
  • All subjects assessed during routine pre-operative assessment in their respective hospital will have been assigned an American Society of Anesthesiologists (ASA) up to grade 3 out of a total of 6 (defined as 'severe systemic disease that limits activity but is not incapacitating').
  • Patients who have undergone previous hip injection for treatment of osteoarthritic symptoms.
  • All surgical approaches (anterior, lateral and posterior), cemented and un-cemented prostheses and all size femoral head size.

Exclusion Criteria:

  • The operating consultant declined participation in the study.
  • The participant previously had hip surgery to the same hip, including arthroscopy, revision hip surgery or treatment for Avascular Necrosis.
  • ASA grade 4 or above 'A patient with severe systemic disease that is a constant threat to life.'
  • Patients with specifically identified increased risk of dislocation (for example neuromuscular disease, hypermobility)
  • Complex primary hip replacement (THR with femoral osteotomy or structural bone grafting / augmentation of acetabulum)
  • Patients unable to complete the postal outcome measures.
  • Any patient with pre-operative cognitive impairment (Dementia or Learning disabilities).
  • Patients undergoing THR for treatment of fractured neck of femur.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Rehabilitation with precautions
Patients in this arm will continue with rehabilitation following routine care recommendations after total hip replacement; therefore following precautions.
Experimental: Rehabilitation with no precautions
Patients in this arm will continue with rehabilitation after total hip replacement without precautions, being permitted to move within limits of their own pain only.
Behavioral: Rehabilitation with no precautions
Patients will recover from total hip replacement surgery being guided by pain only and not by the precautions imposed upon them by clinicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Hip Score (OHS)
Time Frame: assessed at baseline, 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
Consists of 12 items measuring pain, activity, joint mobility and ambulatory activity using a 5 point ordinal Likert Scale over the previous 4 weeks. The total score for the OHS range from 12-60 with the lowest score of 12 signifying the least limited function and the highest score of 60 signifying the most limited function.
assessed at baseline, 6 and 12 weeks after total hip replacement to assess change at each time point following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
The Pittsburgh Sleep Quality Index (PSQI) is an outcome measure designed to assess sleep quality, disturbance and impact on function over the preceding one month. The PSQI measures seven categories. Scores total greater than 5 indicate clinically meaningfully disturbed sleep or poor sleep, less than 4 indicates no problems with sleep
assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
EQ-5D-L
Time Frame: assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery

The lowest score of 0 indicates no functional impairment and a score of 4 indicates significant impairment. The category responses are not combined.

Using a continuous scale on a 20cm vertical visual analogue scale (VAS) a score of 100 means 'the best health imaginable and a score of 0 means 'the worst health imaginable.' EQ5DL Scores at different timepoints are compared to show changes in health over time
assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Investigators

  • Study Chair: JACQUELINE OLDHAM, University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2019

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NHS001514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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