A feasibility randomised controlled trial to evaluate the effectiveness of a novel neuromuscular electro-stimulation device in preventing the formation of oedema following total hip replacement surgery

Thomas W Wainwright, Louise C Burgess, Robert G Middleton, Thomas W Wainwright, Louise C Burgess, Robert G Middleton

Abstract

Aim: The aim of this feasibility study was to investigate the potential role of a novel neuromuscular electrical stimulation (NMES) device in preventing the formation of oedema following total hip replacement (THR).

Methods: Successive primary THR patients were recruited into a randomised controlled trial. Participants were randomised to wear either the NMES device or compression stockings continually from post-surgery until discharge.The main outcome measure was presence of lower limb oedema, assessed by taking measurements of the circumference of the ankle, knee and thigh on the operated leg and non-operated leg, pre-operatively, post-operatively, at two days post-operatively and every day until discharge. Secondary objectives were to compare adverse events, the presence of asymptomatic and symptomatic deep vein thrombosis (DVT) and device tolerability between groups.

Results: Data from 40 participants were analysed (NMES (n = 20), compression stockings (n = 20)). The NMES group had significantly less oedema and the device was found to be tolerable and safe.

Conclusion: The results of this study suggest that the NMES is a safe and well tolerated alternative to compression stockings, which should be considered by clinicians seeking the additional benefit of reducing post-operative oedema. In addition the NMES device should be considered as part of a DVT prophylaxis.

Keywords: Biomedical engineering; Physiology; Rehabilitation; Surgery.

Figures

Fig. 1
Fig. 1
Participant flow diagram. Successive patients undergoing primary THR at the hospital were recruited between 28/08/13 and 09/07/2014 until 40 patients had completed the trial. Follow up of the last patient was completed on 11/08/14. Notes – Subject 021 experienced a “clunking sound” from the operated hip 2 days following the index surgery. An x-ray was performed but was inconclusive, so the subject underwent an exploratory operation. There were no abnormal findings during the procedure, but the operating surgeon (Chief investigator) changed the head of the prosthesis. There was no relation between the SAE and the study device. The investigator made the decision to withdraw this subject from the study prior to discharge.
Fig. 2
Fig. 2
Ankle circumference in the operated leg.
Fig. 3
Fig. 3
Knee circumference in the operated leg.
Fig. 4
Fig. 4
Thigh circumference in the operated leg.

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