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Unrestricted Rehabilitation Pathway Following Total Hip Replacement (ReHip2)

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ClinicalTrials.gov Identifier: NCT03833258
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Justine Theaker, University of Manchester

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE February 6, 2019
Last Update Posted Date February 6, 2019
Estimated Study Start Date  ICMJE May 20, 2019
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
Oxford Hip Score (OHS) [ Time Frame: assessed 6 and 12 weeks after total hip replacement to assess change at each time point following surgery ]
The OHS is a disease specific outcome measure routinely used and recommended to assess improvement in patient's function following Total Hip Replacement. The OHS 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 anchor of 12 signifying the least limited function and 60 signifying the most limited function.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: assessed 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 has been adopted in orthopaedic studies assessing the impact of orthopaedic conditions and surgery on sleep. The PSQI measures seven categories:
    1. Subjective sleep quality
    2. Sleep latency
    3. Sleep duration
    4. Habitual sleep efficiency
    5. Sleep disturbances
    6. Use of sleep medication
    7. Daytime dysfunction Scores greater than 5 indicate clinically meaningfully disturbed sleep or poor sleep
  • EQ-5D-L [ Time Frame: assessed 6 and 12 weeks after total hip replacement to assess change at each time point following surgery ]
    The measure of health related quality of life is recommended in the assessment of new techniques in Total Hip Replacement using the EQ5D-5L. The EQ5D-5L measures health related quality of life (HRQoL) in 5 domains of mobility self-care, usual activities pain/discomfort and anxiety depression over the previous 4 weeks. These domains are assessed in three parts;
    1. Using a descriptive system whereby patients are asked to rate their health, by identifying a response on a Likert scale. The 5 category Likert scale responses to the questions are coded to provide continuous data.
    2. Use of a 20cm vertical visual analogue scale (VAS) with end points of 100 labelled 'the best health imaginable and 0 labelled 'the worst health imaginable.'
    3. Using a continuous scale patients assign a preference value on to each of the health states generated in part 1 of the questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Unrestricted Rehabilitation Pathway Following Total Hip Replacement
Official Title  ICMJE A Randomised Controlled Trial of the Impact on Function of an Unrestricted Rehabilitation Pathway of no Precautions Following Total Hip Replacement
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Total Hip Replacement
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Rehabilitation with no precautions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2019)
182
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Justine Theaker 01612766845 ext 01612766845 justine.theaker@manchester.ac.uk
Contact: JACQUELINE OLDHAM 0161-701-1709 ext 01617011709 jackie.oldham@manchester.ac.uk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03833258
Other Study ID Numbers  ICMJE NHS001514
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Justine Theaker, University of Manchester
Study Sponsor  ICMJE University of Manchester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: JACQUELINE OLDHAM University of Manchester
PRS Account University of Manchester
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP