Hemiarthroplasty Or Total Elbow Arthroplasty in the Elderly.
NCT ID: NCT04646798
Last Updated: 2020-11-30
Study Results
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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UNKNOWN
NA
20 participants
INTERVENTIONAL
2020-11-30
2023-11-30
Brief Summary
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Detailed Description
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Elbow HA allows full lifting and loading activities to continue in the operated elbow. However, the concern is that the metal articulation on native cartilage may result in wear and pain associated with this resulting in the need for conversion to a total elbow prosthesis. As this is revision surgery it carries additional risks over first time surgery. Secondly the collateral ligaments have to be reattached and this risks instability following the surgery if this fails.
Patients with TEA are required to avoid lifting and loading activities with the affected arm from the point of surgery and this is ongoing. Such activity can result in failure of the implant with bushing wear, or early progression to aseptic loosening. However, with complete resection of cartilage there is no concern of progressive ulna wear or pain and some literature has suggested a better range of motion due to the semi-constrained nature of the implant meaning condyle retention is not required.
To date no study has directly compared the two arthroplasty options for DHF's in elderly patients. Both implants are currently offered in the Royal Devon and Exeter, National Health Service Foundation Trust (RD\&E NHS FT), while other trusts locally are known to offer only one approach. This reflect the uncertainty around which treatment may be better: current provision options are based on the operating surgeon's skills and clinical experience.
To address this state of clinical and personal equipoise will require a large, multi-centred, randomised controlled trial of HA vs TEA, for patients over the age of 65 diagnosed with un-reconstructible DHF's. Before this can be considered the investigators need to assess the feasibility of such a study, and obtain preliminary data to inform its development.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hemi Arthroplasty (HA) of the elbow.
Hemi Arthroplasty (HA) of the elbow, where the surgeon replaces the bottom of the humerus bone at the elbow.
Hemiarthroplasty
standard surgical approaches to repair of fractured elbows
Total Elbow Arthroplasty (TEA).
Total Elbow Arthroplasty (TEA), where the surgeon fits a new elbow joint replacing damaged parts of the humerus bone and forearm bone that it joins onto.
Total elbow arthroplasty
standard surgical approaches to repair of fractured elbows
Interventions
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Hemiarthroplasty
standard surgical approaches to repair of fractured elbows
Total elbow arthroplasty
standard surgical approaches to repair of fractured elbows
Eligibility Criteria
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Inclusion Criteria
* Scheduled for operative repair by TEA or HA if fracture deemed unfixable.
* Willing and able to provide informed consent
* Willing and able to be randomly allocated to one of two surgical options
* Willing and able to return for local routine clinical follow up
Exclusion Criteria
* Patients unable to independently consent for inclusion for any reason
* Patients who have had previous elbow joint infections
* Patients who will be unable or unlikely to be able to attend for local routine clinical follow-up (e.g. foreign nationals or holidaymakers who will seek follow-up away from our centre).
65 Years
ALL
Yes
Sponsors
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Royal Devon and Exeter NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Christopher Smith, MBBCH
Role: STUDY_DIRECTOR
Royal Devon and Exeter National Health Service Foundation trust
Locations
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NIHR Exeter Clinical Research Facility
Exeter, Devon, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Christopher Smith, MBBch
Role: primary
Joanne Lowe
Role: backup
References
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McKee MD, Veillette CJ, Hall JA, Schemitsch EH, Wild LM, McCormack R, Perey B, Goetz T, Zomar M, Moon K, Mandel S, Petit S, Guy P, Leung I. A multicenter, prospective, randomized, controlled trial of open reduction--internal fixation versus total elbow arthroplasty for displaced intra-articular distal humeral fractures in elderly patients. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):3-12. doi: 10.1016/j.jse.2008.06.005. Epub 2008 Sep 26.
McKee MD, Wilson TL, Winston L, Schemitsch EH, Richards RR. Functional outcome following surgical treatment of intra-articular distal humeral fractures through a posterior approach. J Bone Joint Surg Am. 2000 Dec;82(12):1701-7. doi: 10.2106/00004623-200012000-00003.
O'Driscoll SW. Optimizing stability in distal humeral fracture fixation. J Shoulder Elbow Surg. 2005 Jan-Feb;14(1 Suppl S):186S-194S. doi: 10.1016/j.jse.2004.09.033.
Huang TL, Chiu FY, Chuang TY, Chen TH. The results of open reduction and internal fixation in elderly patients with severe fractures of the distal humerus: a critical analysis of the results. J Trauma. 2005 Jan;58(1):62-9. doi: 10.1097/01.ta.0000154058.20429.9c.
John H, Rosso R, Neff U, Bodoky A, Regazzoni P, Harder F. [Distal humerus fractures in patients over 75 years of age. Long-term results of osteosynthesis]. Helv Chir Acta. 1993 Sep;60(1-2):219-24. German.
Korner J, Lill H, Muller LP, Hessmann M, Kopf K, Goldhahn J, Gonschorek O, Josten C, Rommens PM. Distal humerus fractures in elderly patients: results after open reduction and internal fixation. Osteoporos Int. 2005 Mar;16 Suppl 2:S73-9. doi: 10.1007/s00198-004-1764-5. Epub 2004 Oct 29.
Pereles TR, Koval KJ, Gallagher M, Rosen H. Open reduction and internal fixation of the distal humerus: functional outcome in the elderly. J Trauma. 1997 Oct;43(4):578-84. doi: 10.1097/00005373-199710000-00003.
Srinivasan K, Agarwal M, Matthews SJ, Giannoudis PV. Fractures of the distal humerus in the elderly: is internal fixation the treatment of choice? Clin Orthop Relat Res. 2005 May;(434):222-30. doi: 10.1097/01.blo.0000154010.43568.5b.
Nestorson J, Ekholm C, Etzner M, Adolfsson L. Hemiarthroplasty for irreparable distal humeral fractures: medium-term follow-up of 42 patients. Bone Joint J. 2015 Oct;97-B(10):1377-84. doi: 10.1302/0301-620X.97B10.35421.
Phadnis J, Watts AC, Bain GI. Elbow hemiarthroplasty for the management of distal humeral fractures: current technique, indications and results. Shoulder Elbow. 2016 Jul;8(3):171-83. doi: 10.1177/1758573216640210. Epub 2016 Apr 21.
Egol K, Koval K, Zuckerman J. Handbook of fractures Fifth Edition. Wolters Kluwer Press
McKee MD, Jupiter JB. Fractures of the distal humerus. In: Browner B, Jupiter J, Levine A, Trafton P, editors. Skeletal trauma. 3rd ed. Philadelphia: Lippincott; 2002. p. 765-82
Burden EG, Batten TJ, Thomas W, Evans JP, Smith C. Hemiarthroplasty or total elbow arthroplasty for unreconstructible distal humeral fractures in the elderly (hot elbow): A feasibility study. Shoulder Elbow. 2025 Apr;17(2):200-208. doi: 10.1177/17585732241244722. Epub 2024 Apr 17.
Other Identifiers
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R&D Study No: 2011059
Identifier Type: -
Identifier Source: org_study_id