Characteristics of PROM validation studies
| Study | Instrument(s) | Primary objective | Country (language) | Population (inclusion/exclusion criteria) | Enrolled (n) | LTFU (n) | Final (n) | Age (years) | Female (%) | FU (months) | Indications for revision | |
| de Groot et al32 | KOOS SF-36 VAS for pain | To validate the Dutch translation of KOOS | Netherlands (Dutch) | Inc: Revision TKR Exclusion: Unable to understand Dutch written language. | 54 | 7 | 47 | 77 (36–89) | 78 | NR | NR | |
| Saleh et al29 | LEAS WOMAC | To develop and validate the Lower Extremity Activity Scale | USA (English) | Inc: First revision TKR capable of completing questionnaires in English and ≥18 years Exc: Re-revision, failed UKR, poly. exchange only, bone tumour, reflex sympathetic dystrophy, unfit for revision TKR, neurological deficit of affected limb, referred pain from spine, declined to participate, concern about compliance, inability to consent, progressive muscular condition of quadriceps, infection delay, stiffness not requiring component revision. | 297 | 12 | 285 | 68.6 (r 34–85) | 55 | 6 | Instability n=82 (28.8%) Tibial osteolysis n=78 (27.4%) Poly. wear n=70 (24.5%) Fem. osteolysis n=64 (22.5%) Tibial loosening n=63 (22.1%) | |
| Ghomrawi et al22 | LEAS SF-36 WOMAC | To characterise patterns of functional improvement after revision total knee arthroplasty over a 2-year period using Lower Extremity Activity Scale | USA (English) | As per Saleh et al29 (2005) | 308 | 87 | 221 | 68.7 (r 34–85) | 55 | 24 | Instability 28.9%* Poly. wear 24.5% Failed poly. insert 18.1% Malalignment 9.4% Tibial loosening 22.2% | Fem. loosening 14.1% Infection 10.4% Tibial lysis 27.5% Fem. lysis 22.5% Patella lysis 9.4% |
| Ghanem et al33 | WOMAC SF-36 KSS 4-point Likert | To determine validity and responsiveness of the Knee Society Rating System | USA (English) | Inc: Revision TKR Exc: Infection (n=85), Patella or poly. exchange only (n=35); Conversion of UKR or internal fixation (n=15), Non-prosthetic failure (n=4) | 165 | 13 | 152 | 67 (r 36–89) | NR | 24 | Mechanical failure: Aseptic loosening 69.7% Knee instability 30.3% |
*Data for this population are provided in a separate paper by Mulhall et al,87 number of patients not provided only percentages.
Age, mean (SD) or (r=indicating range); KOOS, Knee Injury and Osteoarthritis Outcome Score; KSS, Knee Society Rating System; LEAS, Lower Extremity Activity Scale; Lig., ligamentous; LTFU, lost to follow-up; NR, not reported; Poly., polyethylene; PROM, patient-reported outcome measure; SF-36, Short Form 36; WOMAC, Western Ontario and McMaster Universities Arthritis Index.