Hemiarthroplasty Or Total Elbow Arthroplasty in the Elderly. (HOT)

Hemiarthroplasty Or Total Elbow Arthroplasty for Unreconstructible Distal Humerus Fractures in the Elderly (HoT Elbow): a Feasibility Study

A feasibility study to assess the practicality, and obtain preliminary data to inform, a definitive Randomise Control Trial (RCT) in patients over the age of 65 diagnosed with un-reconstructible distal humeral fractures, to determine if there are differences in functional outcomes between those undergoing a hemiarthroplasty and a total elbow arthroplasty? Over an 18 month recruitment period the investigators will assess recruitment rates and participants willingness to be randomised to one of two routine clinical treatments. During a 1 year routine clinical follow up period (at 3 time points), routinely collected orthopaedic outcome data will be recorded and differences between groups explored.

Study Overview

• Status: Not yet recruiting
• Conditions: Distal Humerus Fracture
• Intervention / Treatment: Other: Hemiarthroplasty; Other: Total elbow arthroplasty

Detailed Description

Comminuted intra-articular distal humerus fractures (DHF) in the elderly population (over 65 years) have long been a treatment dilemma. Fixation of the fracture often results in development of arthritis and is associated with severe arthrofibrosis (stiffness) and pain. As a consequence, it has become standard practice that elderly patients with these injuries are treated with either elbow hemiarthroplasty (HA) or total elbow arthroplasty (TEA). Both allow immediate mobilisation of the affected arm, with good long term pain and range of motion outcomes reported for both implants in a variety of articles. However each implant has its own advantages and disadvantages.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Smith, MBBch,; Phone Number: +44 1392403560; Email: christophersmith3@nhs.net
• Study Contact Backup: Name: Bridget A Knight, PhD; Phone Number: +44 1392408172; Email: B.A.Knight@ex.ac.uk

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • NIHR Exeter Clinical Research Facility
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon and Exeter NHS Foundation Trust
      • Contact: Christopher Smith, MBBch; Phone Number: +44 1392403560; Email: christophersmitht3@nhs.net
      • Contact: Joanne Lowe; Phone Number: +44 139240; Email: joanne.lowe3@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 65 or over at time of surgery
• 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:

• Aged under 65 at time of surgery
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Hemiarthroplasty; standard surgical approaches to repair of fractured elbows
Active Comparator: 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.	Other: Total elbow arthroplasty; standard surgical approaches to repair of fractured elbows

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rates	The number of patients willing to be recruited to the study will be presented as a percentage of the number who were approached, as having met the study inclusion criteria, and invited to join the study.	1-18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
randomisation/retention rates	The number of participants randomised to either of the treatment arms will be presented as a percentage of those recruited (randomisation rate). The number of participants completing all stages of the data collection phases will be presented as a percentage of the number of participants randomised and recruited (retention rate).	1-30 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in clinical outcomes between groups as measured by the Oxford Elbow Score (OES) .	The OES is a short 12-item Patient Recorded Outcome measure specifically designed to assess outcomes of elbow surgery across 3 unidimensional domains: Elbow function, Pain and Social-psychological.	30-36 months

Collaborators and Investigators

• Sponsor: Royal Devon and Exeter NHS Foundation Trust
• Investigators: Study Director: Christopher Smith, MBBCH, Royal Devon and Exeter National Health Service Foundation trust

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Anticipated): November 30, 2020
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Humeral Fractures
• Other Study ID Numbers: R&D Study No: 2011059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: feasibility study only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No