PMID- 31094991
OWN - NLM
STAT- MEDLINE
DCOM- 20191223
LR  - 20191223
IS  - 1535-1386 (Electronic)
IS  - 0021-9355 (Linking)
VI  - 101
IP  - 10
DP  - 2019 May 15
TI  - The Feasibility of a Randomized Controlled Trial for Open Tibial Fractures at a 
      Regional Hospital in Uganda.
PG  - e44
LID - 10.2106/JBJS.18.01079 [doi]
AB  - BACKGROUND: The inclusion of low and middle-income country (LMIC) hospitals in 
      multicenter orthopaedic trials expands the pool of eligible patients and improves 
      the external validity of the evidence. Furthermore, promoting studies in LMIC 
      hospitals defines the optimal treatments for low-resource settings, the 
      conditions under which the majority of musculoskeletal injuries are treated. The 
      objective of this study was to determine the feasibility of a randomized 
      controlled trial comparing external fixation with intramedullary (IM) nailing in 
      patients with an isolated open tibial fracture who presented to a regional 
      hospital in Uganda. METHODS: From July 2016 to July 2017, skeletally mature 
      patients who presented to a Ugandan regional hospital with an isolated 
      Gustilo-Anderson type-II or IIIA open fracture of the tibial shaft were eligible 
      for inclusion. The primary feasibility outcomes were the enrollment rate, the 
      recruitment rate, and the 3 and 12-month follow-up rates. The secondary outcomes 
      included a comparison of 3 and 12-month follow-up rates between the treatment 
      arms and a qualitative assessment of barriers to enrollment, timely treatment, 
      and missed follow-up. RESULTS: During the 12-month enrollment period, 37.5% (30 
      of 80) of eligible patients were successfully enrolled and operatively treated on 
      the basis of their random allocation, with an enrollment rate of 2.5 patients per 
      month. Of the 30 enrolled patients, 53% completed their 3-month follow-up 
      appointment, and 40% completed their 1-year follow-up appointment. Rates of 
      1-year follow-up were significantly higher for patients receiving IM nails than 
      for those receiving external fixation (absolute difference, 52%; 95% confidence 
      interval [CI], 21 to 83, p < 0.01). The main reasons that patients declined to 
      participate in the trial were preferences for treatment by traditional 
      bonesetters and prehospital delays that were related to a disorganized referral 
      system. Barriers to follow-up included prohibitive transportation costs and 
      community pressure to turn to traditional forms of treatment. CONCLUSIONS: A 
      regional hospital in Uganda can successfully enroll, randomize, and operatively 
      treat multiple patients with an open tibial fracture each month. Patient 
      follow-up presents substantial concerns over trial feasibility in this setting. 
      Cultural pressure to utilize traditional treatments remains a particularly common 
      barrier to study-participant enrollment and retention.
FAU - Kisitu, Daniel K
AU  - Kisitu DK
AD  - Mbarara University of Science and Technology, Mbarara, Uganda.
FAU - Stockton, David J
AU  - Stockton DJ
AD  - Department of Orthopaedics (D.J.S., P.A.B., and P.J.O.), and Clinician 
      Investigator Program (D.J.S.), University of British Columbia, Vancouver, British 
      Columbia, Canada.
FAU - O'Hara, Nathan N
AU  - O'Hara NN
AD  - Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, 
      Maryland.
FAU - Slobogean, Gerard P
AU  - Slobogean GP
AD  - Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, 
      Maryland.
FAU - Howe, Andrea L
AU  - Howe AL
AD  - Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, 
      Maryland.
FAU - Marinos, Dimitrius
AU  - Marinos D
AD  - Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, 
      Maryland.
FAU - Peck, Connor
AU  - Peck C
AD  - Yale School of Medicine, New Haven, Connecticut.
FAU - Blachut, Piotr A
AU  - Blachut PA
AD  - Department of Orthopaedics (D.J.S., P.A.B., and P.J.O.), and Clinician 
      Investigator Program (D.J.S.), University of British Columbia, Vancouver, British 
      Columbia, Canada.
FAU - O'Brien, Peter J
AU  - O'Brien PJ
AD  - Department of Orthopaedics (D.J.S., P.A.B., and P.J.O.), and Clinician 
      Investigator Program (D.J.S.), University of British Columbia, Vancouver, British 
      Columbia, Canada.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Bone Joint Surg Am
JT  - The Journal of bone and joint surgery. American volume
JID - 0014030
SB  - IM
MH  - Adult
MH  - Developing Countries
MH  - Feasibility Studies
MH  - Follow-Up Studies
MH  - Fracture Fixation/*methods
MH  - Fracture Fixation, Intramedullary
MH  - Fracture Healing
MH  - Fractures, Open/*surgery
MH  - Health Services Accessibility
MH  - Hospitals
MH  - Humans
MH  - Lost to Follow-Up
MH  - Patient Acceptance of Health Care
MH  - Patient Selection
MH  - Prospective Studies
MH  - Tibial Fractures/*surgery
MH  - Treatment Outcome
MH  - Uganda
EDAT- 2019/05/17 06:00
MHDA- 2019/12/24 06:00
CRDT- 2019/05/17 06:00
PHST- 2019/05/17 06:00 [entrez]
PHST- 2019/05/17 06:00 [pubmed]
PHST- 2019/12/24 06:00 [medline]
AID - 00004623-201905150-00015 [pii]
AID - 10.2106/JBJS.18.01079 [doi]
PST - ppublish
SO  - J Bone Joint Surg Am. 2019 May 15;101(10):e44. doi: 10.2106/JBJS.18.01079.