Table 3.

Overview on recommendations with voting results at the consensus conference

Recommendation		% of delegate votes			Eligible to vote
		Agree	Disagree	Abstain
1	There may be indications for the application of THA or TKA implants for purposes outside the one for which the manufacturer intended both in primary and revision arthroplasty (off-label use).	100 % (n = 26)	0%	0%	26
2	Prior to the application of a medical device for hip or knee arthroplasty off-label, surgeons should balance the risks and benefits to the patient, obtain informed consent, and document the decision process appropriately.	100% (n = 26)	0%	0%	26
3	In obese patients, primary and revision arthroplasty is associated with increased peri- and postoperative risks. Off-label use of implants must be considered carefully by surgeons and patients.	100% (n = 25)	0%	0%	25
4	Due to product liability it is commonly accepted in primary THA to use all components from one manufacturer. If evidence suggests, however, that the combination of devices from different manufacturers has superior results, patients may benefit from selective and documented application of mixing and matching.	96.15%(n = 25)	3.85% (n = 1)	0%	26
5	When, in revision THA and TKA, only one component needs revising, mix & match should be allowed. Taking the patient’s risk-benefit balance, the available evidence and the current state of the art into account, surgeons should be allowed to avoid replacing a component purely to avoid mix & match.	100% (n = 28)	0%	0%	28
6	It is crucial for surgeons to only combine implants that are compatible. Mismatch of components, where their sizes or connections do not fit, may have catastrophic effects. It is essential that appropriate measures should be put in place to avoid component mismatch.	100% (n = 29)	0%	0%	29
7	As always, surgeons must be fully aware of the features of the components that they use off-label, must be appropriately trained and must audit their results.	100% (n = 29)	0%	0%	29
8	As mix & match is an off-label procedure, the reasons should be explained to the patient and informed consent obtained.	96.43% (n = 27)	0%	3.57% (n = 1)	28
9	If the application of off-label and mix & match follows recommendations 1–8 for the clinical benefit of the patient, surgeons should not be considered as ‘implant manufacturers’.	89.29% (n = 25)	3.57% (n = 1)	7.14% (n = 2)	28
10	Further research is necessary to obtain more data about the appropriate indications and outcomes for off-label procedures in THA and TKA.	100% (n = 27)	0%	0%	27
11	Where manufacturers have ceased regular production of an implant, they make provision for some of these legacy devices to remain available when required in revision operations. This initiative should be supported by regulators to ensure simplified re-certification.	100% (n = 27)	0%	0%	27
12	In order to ensure safety of head-taper assembly in THA, standardization committees and implant manufacturing industry are encouraged to develop a uniform definition which integrates geometric and topographical features of the taper to reduce the potential of incompatibility.	90.0% (n = 27)	3.33% (n = 1)	6.67% (n = 2)	30