Unrestricted Rehabilitation Pathway Following Total Hip Replacement

NCT03833258 | Terminated DMC

• 1 other identifier: NHS001514
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

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.

Conditions

Total Hip Replacement

Keywords

THR; THA; Total Hip Arthroplasty; Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Oxford Hip Score (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 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 Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI)

  assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery

• EQ-5D-L

  assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery

Study Arms (2)

Rehabilitation with precautions

NO INTERVENTION

Patients in this arm will continue with rehabilitation following routine care recommendations after total hip replacement; therefore following precautions.

Rehabilitation with no precautions

EXPERIMENTAL

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

Interventions

Rehabilitation with no precautions BEHAVIORAL

Patients will recover from total hip replacement surgery being guided by pain only and not by the precautions imposed upon them by clinicians.

Rehabilitation with no precautions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (2)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Wrightington Wigan and Leigh NHS Foundation Trust

Wigan, WN6 9EP, United Kingdom

Location

Related Publications (33)

• 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.

  PMID: 18828962 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.

  PMID: 16264121 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.

  PMID: 14711939 BACKGROUND

• Charnley J. Total hip replacement by low-friction arthroplasty. Clin Orthop Relat Res. 1970 Sep-Oct;72:7-21. No abstract available.

  PMID: 5459811 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.

  PMID: 27374001 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.

  PMID: 19968217 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.

  PMID: 21076896 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.

  PMID: 15469226 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.

  PMID: 19277807 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.

  PMID: 24476806 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.

  PMID: 17197308 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.

  PMID: 14974039 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.

  PMID: 8534389 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.

  PMID: 16344996 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.

  PMID: 26328242 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.

  PMID: 25556661 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.

  PMID: 15687143 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.

  PMID: 12478510 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.

  PMID: 26413601 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.

  PMID: 24187356 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.

  PMID: 25118616 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.

  PMID: 12377909 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.

  PMID: 21163481 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.

  PMID: 18450615 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.

  PMID: 2748771 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.

  PMID: 20550019 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.

  PMID: 14620970 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.

  PMID: 29423757 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.

  PMID: 16264136 BACKGROUND

• Etienne A, Cupic Z, Charnley J. Postoperative dislocation after Charnley low-friction arthroplasty. Clin Orthop Relat Res. 1978 May;(132):19-23.

  PMID: 567107 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.

  PMID: 12728433 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.

  PMID: 16247896 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.

  PMID: 26213480 BACKGROUND

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• JACQUELINE OLDHAM

  University of Manchester

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 6, 2019
• Study Start: August 22, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)