TY - JOUR
T1 - Knee Fix or Replace Trial (KFORT): A randomized controlled feasibility study
AU - Hull, Peter D.
AU - Chou, Daud T. S.
AU - Lewis, Sophie
AU - Carrothers, Andrew D.
AU - Queally, Joseph M.
AU - Allison, Annabel
AU - Barton, Gary
AU - Costa, Matthew L.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - AIMS: The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients. PATIENTS AND METHODS: Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients' willingness to participate, clinicians' willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury. RESULTS: Of 36 patients who met the inclusion criteria, five declined to participate and eight were not recruited, leaving 23 patients to be randomized. One patient withdrew before surgery. Of the remaining patients, five (23%) withdrew during the follow-up period and six (26%) died. A 100% response rate was achieved for the EQ-5D at each follow-up point, excluding one missing datapoint at baseline. In the DFR group, the mean cost of the implant outweighed the mean cost of many other items, including theatre time, length of stay, and readmissions. For a powered RCT, a total sample size of 1400 would be required with 234 centres recruiting over three years. At six months, the EQ-5D utility index was lower in the DFR group. CONCLUSION: This study found that running a full-scale trial in this country would not be feasible. However, it may be feasible to undertake an international multicentre trial, and our findings provide some guidance about the power of such a study, the numbers required, and some challenges that should be anticipated and addressed. Cite this article: Bone Joint J 2019;101-B:1408-1415.
AB - AIMS: The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients. PATIENTS AND METHODS: Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients' willingness to participate, clinicians' willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury. RESULTS: Of 36 patients who met the inclusion criteria, five declined to participate and eight were not recruited, leaving 23 patients to be randomized. One patient withdrew before surgery. Of the remaining patients, five (23%) withdrew during the follow-up period and six (26%) died. A 100% response rate was achieved for the EQ-5D at each follow-up point, excluding one missing datapoint at baseline. In the DFR group, the mean cost of the implant outweighed the mean cost of many other items, including theatre time, length of stay, and readmissions. For a powered RCT, a total sample size of 1400 would be required with 234 centres recruiting over three years. At six months, the EQ-5D utility index was lower in the DFR group. CONCLUSION: This study found that running a full-scale trial in this country would not be feasible. However, it may be feasible to undertake an international multicentre trial, and our findings provide some guidance about the power of such a study, the numbers required, and some challenges that should be anticipated and addressed. Cite this article: Bone Joint J 2019;101-B:1408-1415.
KW - Distal femoral fracture
KW - Distal femoral replacement
KW - Internal fracture fixation
KW - Older patient
UR - http://www.scopus.com/inward/record.url?scp=85074339710&partnerID=8YFLogxK
U2 - 10.1302/0301-620X.101B11.BJJ-2019-0370.R2
DO - 10.1302/0301-620X.101B11.BJJ-2019-0370.R2
M3 - Article
C2 - 31674250
AN - SCOPUS:85074339710
VL - 101-B
SP - 1408
EP - 1415
JO - Bone & Joint Journal
JF - Bone & Joint Journal
SN - 2049-4394
IS - 11
ER -