Unrestricted Rehabilitation Pathway Following Total Hip Replacement
NCT ID: NCT03833258
Last Updated: 2022-11-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
95 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-08-22
Study Completion Date
2021-04-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Total Hip Replacement
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Rehabilitation with precautions
Patients in this arm will continue with rehabilitation following routine care recommendations after total hip replacement; therefore following precautions.
Group Type
NO_INTERVENTION
No interventions assigned to this group
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.
Group Type
EXPERIMENTAL
Rehabilitation with no precautions
Intervention Type
BEHAVIORAL
Patients will recover from total hip replacement surgery being guided by pain only and not by the precautions imposed upon them by clinicians.
Interventions
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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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Manchester
OTHER
Sponsor Role
lead
Responsible Party
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Justine Theaker
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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JACQUELINE OLDHAM
Role: STUDY_CHAIR
University of Manchester
Locations
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Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Site Status
Wrightington Wigan and Leigh NHS Foundation Trust
Wigan, , United Kingdom
Site Status
Countries
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United Kingdom
References
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Blom AW, Rogers M, Taylor AH, Pattison G, Whitehouse S, Bannister GC. Dislocation following total hip replacement: the Avon Orthopaedic Centre experience. Ann R Coll Surg Engl. 2008 Nov;90(8):658-62. doi: 10.1308/003588408X318156. Epub 2008 Sep 30.
Reference Type
BACKGROUND
Berry DJ, von Knoch M, Schleck CD, Harmsen WS. Effect of femoral head diameter and operative approach on risk of dislocation after primary total hip arthroplasty. J Bone Joint Surg Am. 2005 Nov;87(11):2456-63. doi: 10.2106/JBJS.D.02860.
Reference Type
BACKGROUND
Berry DJ, von Knoch M, Schleck CD, Harmsen WS. The cumulative long-term risk of dislocation after primary Charnley total hip arthroplasty. J Bone Joint Surg Am. 2004 Jan;86(1):9-14. doi: 10.2106/00004623-200401000-00003.
Reference Type
BACKGROUND
Charnley J. Total hip replacement by low-friction arthroplasty. Clin Orthop Relat Res. 1970 Sep-Oct;72:7-21. No abstract available.
Reference Type
BACKGROUND
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(7):CD010815. doi: 10.1002/14651858.CD010815.pub2.
Reference Type
BACKGROUND
Ververeli PA, Lebby EB, Tyler C, Fouad C. Evaluation of reducing postoperative hip precautions in total hip replacement: a randomized prospective study. Orthopedics. 2009 Dec;32(12):889. doi: 10.3928/01477447-20091020-09.
Reference Type
BACKGROUND
Restrepo C, Mortazavi SM, Brothers J, Parvizi J, Rothman RH. Hip dislocation: are hip precautions necessary in anterior approaches? Clin Orthop Relat Res. 2011 Feb;469(2):417-22. doi: 10.1007/s11999-010-1668-y.
Reference Type
BACKGROUND
Soong M, Rubash HE, Macaulay W. Dislocation after total hip arthroplasty. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):314-21. doi: 10.5435/00124635-200409000-00006.
Reference Type
BACKGROUND
Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10.
Reference Type
BACKGROUND
Mikkelsen LR, Petersen MK, Soballe 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.
Reference Type
BACKGROUND
Duwelius PJ, Burkhart RL, Hayhurst JO, Moller H, Butler JB. Comparison of the 2-incision and mini-incision posterior total hip arthroplasty technique: a retrospective match-pair controlled study. J Arthroplasty. 2007 Jan;22(1):48-56. doi: 10.1016/j.arth.2006.09.012.
Reference Type
BACKGROUND
Jolles BM, Bogoch ER. Posterior versus lateral surgical approach for total hip arthroplasty in adults with osteoarthritis. Cochrane Database Syst Rev. 2004;(1):CD003828. doi: 10.1002/14651858.CD003828.pub2.
Reference Type
BACKGROUND
Krotenberg R, Stitik T, Johnston MV. Incidence of dislocation following hip arthroplasty for patients in the rehabilitation setting. Am J Phys Med Rehabil. 1995 Nov-Dec;74(6):444-7. doi: 10.1097/00002060-199511000-00010.
Reference Type
BACKGROUND
Masaoka T, Yamamoto K, Shishido T, Katori Y, Mizoue T, Shirasu H, Nunoda D. Study of hip joint dislocation after total hip arthroplasty. Int Orthop. 2006 Feb;30(1):26-30. doi: 10.1007/s00264-005-0032-4. Epub 2005 Dec 13.
Reference Type
BACKGROUND
Barnsley L, Barnsley L, Page R. Are Hip Precautions Necessary Post Total Hip Arthroplasty? A Systematic Review. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):230-5. doi: 10.1177/2151458515584640.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.2106/JBJS.C.01513.
Reference Type
BACKGROUND
Talbot NJ, Brown JH, Treble NJ. Early dislocation after total hip arthroplasty: are postoperative restrictions necessary? J Arthroplasty. 2002 Dec;17(8):1006-8. doi: 10.1054/arth.2002.34534.
Reference Type
BACKGROUND
Gromov K, Troelsen A, Otte KS, Orsnes 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. No abstract available.
Reference Type
BACKGROUND
Brooks PJ. Dislocation following total hip replacement: causes and cures. Bone Joint J. 2013 Nov;95-B(11 Suppl A):67-9. doi: 10.1302/0301-620X.95B11.32645.
Reference Type
BACKGROUND
Jorgensen 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.
Reference Type
BACKGROUND
Alberton GM, High WA, Morrey BF. Dislocation after revision total hip arthroplasty : an analysis of risk factors and treatment options. J Bone Joint Surg Am. 2002 Oct;84(10):1788-92.
Reference Type
BACKGROUND
Ahmad MA, Xypnitos FN, Giannoudis PV. Measuring hip outcomes: common scales and checklists. Injury. 2011 Mar;42(3):259-64. doi: 10.1016/j.injury.2010.11.052. Epub 2010 Dec 15.
Reference Type
BACKGROUND
Ashby E, Grocott MP, Haddad FS. Outcome measures for orthopaedic interventions on the hip. J Bone Joint Surg Br. 2008 May;90(5):545-9. doi: 10.1302/0301-620X.90B5.19746.
Reference Type
BACKGROUND
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Reference Type
BACKGROUND
Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.
Reference Type
BACKGROUND
Bystrom S, Espehaug B, Furnes O, Havelin LI; Norwegian Arthroplasty Register. Femoral head size is a risk factor for total hip luxation: a study of 42,987 primary hip arthroplasties from the Norwegian Arthroplasty Register. Acta Orthop Scand. 2003 Oct;74(5):514-24. doi: 10.1080/00016470310017893.
Reference Type
BACKGROUND
Conner-Spady BL, Marshall DA, Bohm E, Dunbar MJ, Noseworthy TW. Comparing the validity and responsiveness of the EQ-5D-5L to the Oxford hip and knee scores and SF-12 in osteoarthritis patients 1 year following total joint replacement. Qual Life Res. 2018 May;27(5):1311-1322. doi: 10.1007/s11136-018-1808-5. Epub 2018 Feb 8.
Reference Type
BACKGROUND
Cummins JS, Weinstein JN. The role of patient restrictions in reducing the prevalence of early dislocation following total hip arthroplasty. J Bone Joint Surg Am. 2005 Nov;87(11):2587; author reply 2587-8. doi: 10.2106/00004623-200511000-00028. No abstract available.
Reference Type
BACKGROUND
Etienne A, Cupic Z, Charnley J. Postoperative dislocation after Charnley low-friction arthroplasty. Clin Orthop Relat Res. 1978 May;(132):19-23.
Reference Type
BACKGROUND
Fielden JM, Gander PH, Horne JG, Lewer BM, Green RM, Devane PA. An assessment of sleep disturbance in patients before and after total hip arthroplasty. J Arthroplasty. 2003 Apr;18(3):371-6. doi: 10.1054/arth.2003.50056.
Reference Type
BACKGROUND
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. doi: 10.1136/ebn.8.4.115. No abstract available.
Reference Type
BACKGROUND
Gibbons E, Hewitson P, Morley D, Jenkinson C, Fitzpatrick R. The Outcomes and Experiences Questionnaire: development and validation. Patient Relat Outcome Meas. 2015 Jul 16;6:179-89. doi: 10.2147/PROM.S82784. eCollection 2015.
Reference Type
BACKGROUND
Other Identifiers
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NHS001514
Identifier Type: -
Identifier Source: org_study_id
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