Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly - A Multicenter Randomized trial

Fractures of the proximal humerus are common injuries in the elderly. The
incidence is approximately 6.6 per 1000 person years. Most of these fractures
can be treated with non-operative means and careful early motion. However, the
treatment of complex fractures like selected three-or four-part fractures and
split fractures of the humeral head is a demanding and unresolved problem.
Locking plates have recently been introduced and they appear to offer
improved fixation. However, especially in elderly patients the prevalence of
screw cut-out ranges from 11 to 43% due to fracture collapse. This may
ultimately lead to higher rates of revision surgery. Therefore, it seems
reasonable to treat these complex fractures primarily with a prosthesis or
non-operatively in a population of elderly patients.
Primary hemiarthroplasty and non-operative treatment of complex
proximal humeral fractures have been described in a number of studies with
varying functional results. Stableforth et al. performed a randomized study
comparing hemiarthroplasty with conservative management in a total of 32
patients. The results revealed less pain and better overall function in the
hemiarthroplasty group. However, this study had methodological limitations
because of indistinct inclusion criteria and a difference in age between the
two intervenion arms at baseline, and may therefore not be generalizable. To
our notice no other randomized controlled trial has been performed to compare
hemiarthroplasty and non*operative treatment of complex fractures of the
proximal humerus.

Primary objective
To compare the Constant scores (reflecting functional outcome and pain) at one
year after primary hemiarthroplasty versus non-operative treatment in patients
over 65 years of age who sustained a complex humeral fracture.

Secondary objectives
1. To compare the Constant scores (reflecting functional outcome and pain) at
six months and two year after primary hemiarthroplasty versus non-operative
treatment in patients over 65 years of age who sustained a complex humeral
fracture
2. To examine the effect of primary hemiarthroplasty versus non-operative
treatment on the degree of disabilities of the arm, shoulder and hand (DASH
score) as well as on sports/music performance (DASH optional module)
3. To examine the effect of primary hemiarthroplasty versus non-operative
treatment on the level of pain experienced by the patients (VAS)
4. To examine the effect of primary hemiarthroplasty versus non-operative
treatment on the rate of secondary interventions, complications and mortality
5. To examine the effect of primary hemiarthroplasty versus non-operative
treatment on health-related quality of life (SF-36, EQ-5D)
6. To assess the costs and cost-effectiveness ratio of primary hemiarthroplasty
versus non-operative treatment
7. To identify the healing and position of the tuberculi based on CT and
radiographs

Multicenter randomized controlled trial

One group will receive a hemiarthroplasty (Affinis® Fracture shoulder
endoprosthesis (Mathys AG Bettlach)).
Critical aspects of the surgical procedure will be standardized. After surgery,
patients are allowed to use a sling for 2 days to one week. Patients will
receive after-treatment following a standardized approach. Anteflexion and
elevation exercises may be started immediately if tolerated. Rotation exercises
against resistance are not allowed during the first six weeks after surgery.

The other group will be treated non-operatively.
The affected arm will be put in a collar and cuff for three weeks. At one week
after fracture circumduction exercises will start. At three weeks after
fracture mobilization will be initiated by practicing under supervision of a
physical therapist. Physical therapy sessions will be held at regular
intervals, preferably 2 times a week during 12 weeks. The exact frequency and
duration of physical therapy will largely depend upon the extent of functional
recovery. This will be left at the discretion of the therapist.

Both interventions are standard of care treatment modalities.

The clinic follow-up visits at t=1, 3 and 6 weeks, and 3, 6, 12 and 24 months
are part of Standard of Care. The same holds true for the X-rays at t=1,3 and 6
weeks, and 3 and 12 months and the pre-operative CT-scan (for fracture
classification).

For research purposes, one single CT scan of the schoulder will be made at 12
monthts in order to assess the degree of radiographic healing. The effective
radiation due to this CT scan is mild. An additional risk associated with
participating in this trial is the completion of a set of questionnaires. There
are no risks involved in that.