Table 5. Adverse effects associated with included studies.

Study	Experimental Group Adverse Effects	Comparison / Control Group Adverse Effects
Chen H et al 2012 [30]	Prosthetic infection, results not indicated DVT, results not indicated	Prosthetic infection, results not indicated DVT, results not indicated
den Hertog et al 2012 [44]	Deep infection Stiffness Urinary tract infection Subluxation of the patella Tibial fissure	Humerus fracture Stiffness Urinary tract infection Subluxation of the patella Tibial fissure
Gulotta et al 2011 [46]	Dislocation, resulting in re-admission treated with a closed reduction in emergency department Periprosthetic femoral fracture, resulting in re-admission treated with a femoral revision Early aseptic loosening, resulting in re-admission treated with acetabular cup revision Significant anemia, resulting in re-admission treated with blood transfusion Gastrointestinal bleed POD 1, resulting transfer to medical ICU Pulmonary embolus POD 1, leading to atrial fibrillation	Dislocation, resulting in re-admission treated with open reduction and revision of prosthesis
Isaac et al 2005 [47]	Delayed recovery in renal function, resulting in hospital stay extended 7 days Suspected DVT, resulting in re-admission to hospital. Subsequent duplex ultrasound scanning demonstrated no DVT Failure to cope at home, with associated leg and ankle pain, resulting in re-admission to hospital
Larsen et al 2008 [35]	One major perioperative complication related to THA implant—not indicated, resulting in no effect on LOS Respiratory arrest after pneumonia, resulting in death Re-admission to hospital, adverse effects not indicated	Re-admission to hospital, adverse effects not indicated Respiratory arrest after pneumonia, resulting in death
Larsen et al 2008* [36]	Swelling and pain in knee, resulting in re-admission, LOS 11 days Hip dislocation, resulting in re-admission, LOS 1 day	PE, resulting in death day after surgery Wound Infection, resulting in re-admission to hospital, revision surgery, additional LOS 15 days
Pua & Ong 2014 [37]	Re-admission to hospital, adverse effects not indicated	Re-admission to hospital, adverse effects not indicated
Raphael et al 2011 [50]	Intra-operative electrocardiogram changes, resulting in increased LOS 3–4 days. Subsequent cardiology consultation and dobutamine stress echocardiogram demonstrated no coronary ischemia. Chest pain, resulting in increased LOS 3–4 days. Subsequent cardiology consultation and dobutamine stress echocardiogram demonstrated no coronary ischemia. Post-operative hematoma and infection, resulting in re-admission Emergency department visits, adverse effects not indicated Re-admission to hospital, adverse effects not indicated	Inadequate pain control, resulting in re-admission Emergency department visits, adverse effects not indicated Re-admission to hospital, adverse effects not indicated
Reilly et al 2005 [45]	Bleed following removal of drain Poor ROM (50 degrees of flexion), resulting in re-admission to hospital treated with MUA Superficial wound infection Episode of low blood pressure Suspected DVT. Subsequent testing demonstrated no DVT.	Deep wound infection, resulting in re-admission to hospital treated with outpatient antibiotics Suspected DVT. Subsequent testing demonstrated no DVT.
Robbins et al 2014 [38]	Right thigh hematoma, resulting in re-admission to hospital, LOS 7 days secondary to muscle spasms limiting functional mobility; pain; and symptomatic anemia	Hip pain, resulting in re-admission to hospital Hip infection, resulting in admission to hospital’s ambulatory care unit, intravenous antibiotics administered Significant leg length discrepancy detected in PACU, returned to OR same DOS for THA revision Other complications: tachycardia, hypoxia, postoperative anemia, atelectasis, lower extremity swelling, atrial fibrillation, pneumonia, confusion, ileus, respiratory arrest, bradycardia, elevated INR, and lower extremity hematoma
Wellman et al 2011 [40]	I&D for acutely increasing pain, resulting in re-admission 8 months post-op

Abbreviations: DVT, deep vein thrombosis; DOS, day of surgery; I&D, incision and drainage; ICU, intensive care unit; INR, international normalized ratio; POD, post-operative day; LOS, length of stay; MAU, manipulation under anesthesia; OR, operating room; PACU, post-anesthesia care unit; PE, pulmonary embolism; ROM, range of motion; THA, total hip arthroplasty

*Adverse events were reported in the follow-up cost effectiveness study (Larsen et al, 2009), but are not reported here because the study was based on the Larsen et al 2008 RCT and are, therefore, the same.