Guidance
5 Safety
5 Safety
This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 Deep vein thrombosis was reported in 11% (2/19) of patients treated by joint distraction in a non-randomised comparative study of 61 patients treated by joint distraction and debridement (n=19) or debridement alone (n=42); in 1 patient the thrombosis resolved after heparinisation and 1 patient developed a non-fatal pulmonary embolism (no further details provided). Pulmonary embolism was reported in 10% (2/20) of patients in a case series of 20 patients with end-stage knee osteoarthritis; both patients were treated by oral anticoagulants for 6 months (no further details provided).
5.2 Pin track infections were reported in 18% of patients (absolute number not given) treated by knee joint distraction in the non‑randomised comparative study of 61 patients treated by joint distraction and debridement (n=19) or debridement alone (n=42); all patients responded completely to local cleaning and systemic antibiotics (no further details provided). Pin track infections were reported in 85% (17/20) of patients treated by knee joint distraction in the case series of 20 patients; all the infections were treated by oral antibiotics (flucloxacillin; no further details provided). Superficial skin infections around the insertion of the pins were reported in 33% (2/6) of patients treated by knee joint distraction in a case series of 6 patients with knee osteoarthritis (no further details provided).
5.3 Limited flexion immediately after treatment was reported in all patients (20/20) in the case series of 20 patients (mean -31.6º of flexion, 95% confidence interval [CI] -43.9º to -19.2º). Flexion improved at 6 months (mean -7.2º of flexion, 95% CI -15.2º to 1.1º) and flexion range fully normalised within 1 year (mean +2.9º of flexion, 95% CI -3.3º to 9.1º).
5.4 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not list any anecdotal adverse events. They considered that the following were theoretical adverse events: stress fracture at pin site, creation of deformity, pain, risk of worsening symptoms and failure to give benefit.