Clinical trial NCT04646798: Hemiarthroplasty Or Total Elbow Arthroplasty in the Elderly.
Official title: Hemiarthroplasty Or Total Elbow Arthroplasty for Unreconstructible Distal Humerus Fractures in the Elderly (HoT Elbow): a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Humerus Fracture
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Recruitment rates
timeFrame: 1-18 months
Secondary outcomes:
measure: randomisation/retention rates
timeFrame: 1-30 months
Other outcomes:
measure: Differences in clinical outcomes between groups as measured by the Oxford Elbow Score (OES) .
timeFrame: 30-36 months
Locations:
city: Exeter
country: United Kingdom
facility: NIHR Exeter Clinical Research Facility
state: Devon
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
state: Devon
Study officials:
affiliation: Royal Devon and Exeter National Health Service Foundation trust
name: Christopher Smith, MBBCH
role: STUDY_DIRECTOR
References:
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