Unrestricted Rehabilitation Pathway Following Total Hip Replacement (ReHip2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03833258|
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Total Hip Replacement||Behavioral: Rehabilitation with no precautions||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial of the Impact on Function of an Unrestricted Rehabilitation Pathway of no Precautions Following Total Hip Replacement|
|Estimated Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||July 30, 2020|
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.
- 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.
- 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:
- Subjective sleep quality
- Sleep latency
- Sleep duration
- Habitual sleep efficiency
- Sleep disturbances
- Use of sleep medication
- 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;
- 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.
- 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.'
- Using a continuous scale patients assign a preference value on to each of the health states generated in part 1 of the questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833258
|Contact: Justine Theaker||01612766845 ext email@example.com|
|Contact: JACQUELINE OLDHAM||0161-701-1709 ext firstname.lastname@example.org|
|Study Chair:||JACQUELINE OLDHAM||University of Manchester|