Distal Humerus FractureHOTNCT04646798
Hemiarthroplasty Or Total Elbow Arthroplasty in the Elderly.
A study testing Hemiarthroplasty and Total elbow arthroplasty in people with Distal Humerus Fracture, run by Royal Devon and Exeter NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Humerus Fracture
- What is being tested?
- Hemiarthroplasty and Total elbow arthroplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Nov 2020to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NIHR Exeter Clinical Research Facility
Exeter, Devon, EX2 5DW
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW
Christopher Smith, MBBch, +44 1392403560, christophersmitht3@nhs.net
Joanne Lowe, +44 139240, joanne.lowe3@nhs.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Distal Humerus Fracture
- Being tested
- Hemiarthroplasty, Total elbow arthroplasty
- Medical subject headings
- Humeral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemiarthroplastyOther
standard surgical approaches to repair of fractured elbows
Total elbow arthroplastyOther
standard surgical approaches to repair of fractured elbows
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Total elbow arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-18 months
Secondary outcomes (1)
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).
Measured: 1-30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start30 Nov 2020 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Distal Humerus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Smith, MBBCH, Study director, Royal Devon and Exeter National Health Service Foundation trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646798
- Sponsor's protocol ID
- R&D Study No: 2011059
- Acronym
- HOT
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: feasibility study only
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.
PubMed 18823799McKee 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.
PubMed 11130643O'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.
PubMed 15726080Huang 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.
PubMed 15674152John 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.
PubMed 8226060Korner 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.
PubMed 15517186Pereles 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.
PubMed 9356051Srinivasan 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.
PubMed 15864057Nestorson 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.
PubMed 26430013Phadnis 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.
PubMed 27583016Egol 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.
PubMed 39552682
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemiarthroplasty Or Total Elbow Arthroplasty for Unreconstructible Distal Humerus Fractures in the Elderly (HoT Elbow): a Feasibility Study
- ClinicalTrials.gov ID
- NCT04646798
- Acronym / sponsor ID
- HOT / R&D Study No: 2011059
- Conditions
- Distal Humerus Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Hemi Arthroplasty (HA) of the elbow. | Active comparator | Other: HemiarthroplastyHemi Arthroplasty (HA) of the elbow, where the surgeon replaces the bottom of the humerus bone at the elbow. |
| Total Elbow Arthroplasty (TEA). | Active comparator | Other: Total elbow arthroplastyTotal 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemiarthroplastystandard surgical approaches to repair of fractured elbows | Other | Hemi Arthroplasty (HA) of the elbow. |
| Total elbow arthroplastystandard surgical approaches to repair of fractured elbows | Other | Total Elbow Arthroplasty (TEA). |
Primary outcome
Recruitment rates
Time frame: 1-18 months
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 secondary outcome
randomisation/retention rates
Time frame: 1-30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Background: PubMed 18823799McKee 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.
- Background: PubMed 11130643McKee 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.
- Background: PubMed 15726080O'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.
- Background: PubMed 15674152Huang 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.
- Background: PubMed 8226060John 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.
- Background: PubMed 15517186Korner 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.
- Background: PubMed 9356051Pereles 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.
- Background: PubMed 15864057Srinivasan 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.
- Background: PubMed 26430013Nestorson 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.
- Background: PubMed 27583016Phadnis 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.
- BackgroundEgol K, Koval K, Zuckerman J. Handbook of fractures Fifth Edition. Wolters Kluwer Press
- BackgroundMcKee 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
- Individual participant dataSharing planned: No. feasibility study only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Smith, MBBCH study director
Royal Devon and Exeter National Health Service Foundation trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemiarthroplasty and Total elbow arthroplasty in people with Distal Humerus Fracture, run by Royal Devon and Exeter NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Smith, MBBch, (+44 1392403560, christophersmith3@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: 1-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646798, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.