PMID- 37093236
OWN - NLM
STAT- MEDLINE
DCOM- 20230721
LR  - 20230721
IS  - 1433-7347 (Electronic)
IS  - 0942-2056 (Linking)
VI  - 31
IP  - 8
DP  - 2023 Aug
TI  - The reverse fragility index: RCTs reporting non-significant differences in 
      failure rates between hamstring and bone-patellar tendon-bone autografts have 
      fragile results.
PG  - 3412-3419
LID - 10.1007/s00167-023-07420-0 [doi]
AB  - PURPOSE: The reverse fragility index (RFI) is a novel metric to appraise the 
      results of studies reporting statistically non-significant results. The purpose 
      of this study was to determine the statistical robustness of randomized 
      controlled trials (RCTs) reporting non-significant differences in anterior 
      cruciate ligament reconstruction (ACLR) graft failure rates, defined as 
      re-rupture/revision ACLR rate, between hamstring tendon (HT) and bone-patellar 
      tendon-bone (BTB) autografts by calculating RFIs. METHODS: A systematic review 
      was performed to identify RCTs that compared HT to BTB grafts for ACLR through 
      January 2022. Studies reporting non-significant differences in graft re-rupture 
      and revision ACLR rate (n.s.) were included. The RFI, defined as the fewest 
      number of event reversals needed to change the non-significant graft 
      re-rupture/revision outcome to statistically significant (P < 0.05), was recorded 
      for each study. In addition, the number of studies in which the loss to follow-up 
      exceeded the RFI was recorded. RESULTS: Among the 16 included RCTs, the median 
      (interquartile range [IQR]) sample size was 71 (64-114), and the median (IQR) 
      total number of graft re-rupture/revision ACLR events was 4 (4-6). The median 
      (IQR) graft re-rupture/revision ACLR rate was 4.3% (3.0-6.4) overall, 4.1% 
      (2.6-6.7) in the BTB group, and 5.4% (3.0-6.3) in the HT group. The median (IQR) 
      RFI was 3 (3-4), signifying that a reversal of the outcome in 3 patients in one 
      arm was needed to flip the studies' result from non-significant to statistically 
      significant (P < 0.05). The median (IQR) number of participants lost to follow-up 
      was 11 (3-13), and 13 (81.3%) of the included studies had a loss to follow-up 
      greater than the studies' RFI. CONCLUSION: The results of RCTs reporting 
      statistically non-significant re-rupture/revision ACLR rates between HT and BTB 
      autografts would become significant if the outcome were reversed in a small 
      number of patients-a number that was less than the loss to follow-up in the 
      majority of studies. Thus, the neutrality of these studies is fragile, and a true 
      statistically significant difference in re-rupture/revision rates may have been 
      undetected. LEVEL OF EVIDENCE: Level I.
CI  - (c) 2023. The Author(s) under exclusive licence to European Society of Sports 
      Traumatology, Knee Surgery, Arthroscopy (ESSKA).
FAU - Ruelos, Verdinand C B
AU  - Ruelos VCB
AD  - Tufts University School of Medicine, Boston, MA, USA.
FAU - Masood, Raisa
AU  - Masood R
AD  - Department of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend 
      Building, Boston, MA, 02111, USA.
FAU - Puzzitiello, Richard N
AU  - Puzzitiello RN
AD  - Department of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend 
      Building, Boston, MA, 02111, USA.
FAU - Moverman, Michael A
AU  - Moverman MA
AD  - Department of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend 
      Building, Boston, MA, 02111, USA.
FAU - Pagani, Nicholas R
AU  - Pagani NR
AD  - Department of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend 
      Building, Boston, MA, 02111, USA.
FAU - Menendez, Mariano E
AU  - Menendez ME
AD  - Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, IL, USA.
FAU - Salzler, Matthew J
AU  - Salzler MJ
AUID- ORCID: 0000-0002-9928-0879
AD  - Department of Orthopaedic Surgery, Tufts Medical Center, 270 Tremont St Biewend 
      Building, Boston, MA, 02111, USA. MSalzler@tuftsmedicalcenter.org.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20230424
PL  - Germany
TA  - Knee Surg Sports Traumatol Arthrosc
JT  - Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
JID - 9314730
SB  - IM
MH  - Humans
MH  - *Patellar Ligament/surgery
MH  - Autografts/surgery
MH  - *Anterior Cruciate Ligament Injuries/surgery
MH  - *Anterior Cruciate Ligament Reconstruction/methods
MH  - Transplantation, Autologous
MH  - *Hamstring Tendons/transplantation
MH  - Bone-Patellar Tendon-Bone Grafting/methods
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - ACL reconstruction
OT  - Graft selection
OT  - Reverse fragility index
OT  - Sports
EDAT- 2023/04/24 12:41
MHDA- 2023/07/21 06:43
CRDT- 2023/04/24 11:13
PHST- 2022/09/26 00:00 [received]
PHST- 2023/04/14 00:00 [accepted]
PHST- 2023/07/21 06:43 [medline]
PHST- 2023/04/24 12:41 [pubmed]
PHST- 2023/04/24 11:13 [entrez]
AID - 10.1007/s00167-023-07420-0 [pii]
AID - 10.1007/s00167-023-07420-0 [doi]
PST - ppublish
SO  - Knee Surg Sports Traumatol Arthrosc. 2023 Aug;31(8):3412-3419. doi: 
      10.1007/s00167-023-07420-0. Epub 2023 Apr 24.