NCT04646798

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

2.5 years

First QC Date

November 17, 2020

Last Update Submit

November 23, 2020

Conditions

Distal Humerus Fracture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • randomisation/retention rates

    1-30 months

Other Outcomes (1)

  • Differences in clinical outcomes between groups as measured by the Oxford Elbow Score (OES) .

    30-36 months

Study Arms (2)

Hemi Arthroplasty (HA) of the elbow.

ACTIVE COMPARATOR

Hemi Arthroplasty (HA) of the elbow, where the surgeon replaces the bottom of the humerus bone at the elbow.

Other: Hemiarthroplasty

Total Elbow Arthroplasty (TEA).

ACTIVE COMPARATOR

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

Interventions

HemiarthroplastyOTHER

standard surgical approaches to repair of fractured elbows

Hemi Arthroplasty (HA) of the elbow.
Total elbow arthroplastyOTHER

standard surgical approaches to repair of fractured elbows

Total Elbow Arthroplasty (TEA).

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Aged under 65 at time of surgery
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NIHR Exeter Clinical Research Facility

Exeter, Devon, EX2 5DW, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

Related Publications (13)

  • 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.

    PMID: 18823799BACKGROUND

  • 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.

    PMID: 11130643BACKGROUND

  • 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.

    PMID: 15726080BACKGROUND

  • 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.

    PMID: 15674152BACKGROUND

  • 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.

    PMID: 8226060BACKGROUND

  • 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.

    PMID: 15517186BACKGROUND

  • 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.

    PMID: 9356051BACKGROUND

  • 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.

    PMID: 15864057BACKGROUND

  • 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.

    PMID: 26430013BACKGROUND

  • 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.

    PMID: 27583016BACKGROUND

  • Egol K, Koval K, Zuckerman J. Handbook of fractures Fifth Edition. Wolters Kluwer Press

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 39552682DERIVED

MeSH Terms

Conditions

Humeral Fractures, Distal

Interventions

HemiarthroplastyArthroplasty, Replacement, Elbow

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesHumeral FracturesFractures, Bone

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Christopher Smith, MBBCH

    Royal Devon and Exeter National Health Service Foundation trust

    STUDY DIRECTOR

Central Study Contacts

Christopher Smith, MBBch,

CONTACT

+44 1392403560christophersmith3@nhs.net

Bridget A Knight, PhD

CONTACT

+44 1392408172B.A.Knight@ex.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participant and clinician will not be masked. Data outcomes will be assessed by the research team utilising unique study Identifiers only and group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: To assess the feasibility of undertaking a randomised controlled trial of hemiarthroplasty versus total elbow arthroplasty for patients over the age of 65 who have an unreconstructible distal humeral fracture
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 30, 2020

Study Start

November 30, 2020

Primary Completion

May 30, 2023

Study Completion

November 30, 2023

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

feasibility study only

Locations

GB(2)