ReHip2: Unrestricted Rehabilitation Pathway Following Total Hip Replacement
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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;
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Patients must not bend past 90 degrees at the hip (including sitting)
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Patients must not twist in either standing or sitting
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Patients must partial weight bear with elbow crutches for a minimum of 6 weeks
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Patients must sleep on their back for a minimum of 6 weeks
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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 Design
Arms and Interventions
| 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. |
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| 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.
|
Outcome Measures
Primary Outcome Measures
- Oxford Hip Score (OHS) [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.
Secondary Outcome Measures
- Pittsburgh Sleep Quality Index (PSQI) [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. measures will be repeated at baseline, 6 weeks and 12 following surgery
- EQ-5D-L [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult participants over the age of 18 years will be included.
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All participants should be proceeding with routine care unilateral (one side only) primary THR for treatment of osteoarthritis
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The patients operating consultant agreed to involvement of their patients in the study.
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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').
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Patients who have undergone previous hip injection for treatment of osteoarthritic symptoms.
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All surgical approaches (anterior, lateral and posterior), cemented and un-cemented prostheses and all size femoral head size.
Exclusion Criteria:
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The operating consultant declined participation in the study.
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The participant previously had hip surgery to the same hip, including arthroscopy, revision hip surgery or treatment for Avascular Necrosis.
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ASA grade 4 or above 'A patient with severe systemic disease that is a constant threat to life.'
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Patients with specifically identified increased risk of dislocation (for example neuromuscular disease, hypermobility)
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Complex primary hip replacement (THR with femoral osteotomy or structural bone grafting / augmentation of acetabulum)
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Patients unable to complete the postal outcome measures.
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Any patient with pre-operative cognitive impairment (Dementia or Learning disabilities).
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Patients undergoing THR for treatment of fractured neck of femur.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Manchester University NHS Foundation Trust | Manchester | United Kingdom | M13 9WL | |
| 2 | Wrightington Wigan and Leigh NHS Foundation Trust | Wigan | United Kingdom | WN6 9EP |
Sponsors and Collaborators
- University of Manchester
Investigators
- Study Chair: JACQUELINE OLDHAM, University of Manchester
Study Documents (Full-Text)
None provided.More Information
Publications
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- Forster FJ. Relaxing hip precautions increased patient satisfaction and promoted quicker return to normal activities after total hip arthroplasty. Evid Based Nurs. 2005 Oct;8(4):115.
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- Gromov K, Troelsen A, Otte KS, Ørsnes T, Ladelund S, Husted H. Removal of restrictions following primary THA with posterolateral approach does not increase the risk of early dislocation--reply. Acta Orthop. 2015;86(4):518-9.
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- Jørgensen CC, Kjaersgaard-Andersen P, Solgaard S, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Hip dislocations after 2,734 elective unilateral fast-track total hip arthroplasties: incidence, circumstances and predisposing factors. Arch Orthop Trauma Surg. 2014 Nov;134(11):1615-22. doi: 10.1007/s00402-014-2051-3. Epub 2014 Aug 14.
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- Mikkelsen LR, Petersen MK, Søballe K, Mikkelsen S, Mechlenburg I. Does reduced movement restrictions and use of assistive devices affect rehabilitation outcome after total hip replacement? A non-randomized, controlled study. Eur J Phys Rehabil Med. 2014 Aug;50(4):383-93. Epub 2014 Jan 30.
- Peak EL, Parvizi J, Ciminiello M, Purtill JJ, Sharkey PF, Hozack WJ, Rothman RH. The role of patient restrictions in reducing the prevalence of early dislocation following total hip arthroplasty. A randomized, prospective study. J Bone Joint Surg Am. 2005 Feb;87(2):247-53.
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- Schmidt-Braekling T, Waldstein W, Akalin E, Benavente P, Frykberg B, Boettner F. Minimal invasive posterior total hip arthroplasty: are 6 weeks of hip precautions really necessary? Arch Orthop Trauma Surg. 2015 Feb;135(2):271-274. doi: 10.1007/s00402-014-2146-x. Epub 2015 Jan 4.
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- Smith TO, Jepson P, Beswick A, Sands G, Drummond A, Davis ET, Sackley CM. Assistive devices, hip precautions, environmental modifications and training to prevent dislocation and improve function after hip arthroplasty. Cochrane Database Syst Rev. 2016 Jul 4;7:CD010815. doi: 10.1002/14651858.CD010815.pub2. Review.
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