PMID- 32807219
OWN - NLM
STAT- MEDLINE
DCOM- 20210527
LR  - 20220416
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 21
IP  - 1
DP  - 2020 Aug 17
TI  - Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based 
      unicompartmental knee arthroplasty with navigation control: study protocol for a 
      prospective randomised controlled trial.
PG  - 721
LID - 10.1186/s13063-020-04631-5 [doi]
LID - 721
AB  - BACKGROUND: There remains a paucity of clinical studies assessing how any 
      differences in accuracy of implant positioning between robotic-arm assisted 
      unicompartmental knee arthroplasty (RO UKA) and conventional jig-based 
      unicompartmental knee arthroplasty (CO UKA) translate to patient satisfaction, 
      functional outcomes, and implant survivorship. The objectives of this study are 
      to compare accuracy of implant positioning, limb alignment, patient satisfaction, 
      functional outcomes, implant survivorship, cost-effectiveness, and complications 
      in CO UKA versus RO UKA. Computer navigation will be used to assess 
      intraoperative knee kinematics in all patients undergoing CO UKA. METHODS AND 
      ANALYSIS: This prospective randomised controlled trial will include 140 patients 
      with symptomatic medial compartment knee arthritis undergoing primary UKA. 
      Following informed consent, patients will be randomised to CO UKA (control group) 
      or RO UKA (investigation group) at a ratio of 1:1 using an online random number 
      generator. The primary objective of this study is to compare accuracy of implant 
      positioning in CO UKA versus RO UKA. The secondary objectives are to compare the 
      following outcomes between the two treatment groups: limb alignment, surgical 
      efficiency, postoperative functional rehabilitation, functional outcomes, quality 
      of life, range of motion, resource use, cost effectivness, and complications. 
      Observers will review patients at regular intervals for 2 years after surgery to 
      record predefined study outcomes pertaining to these objectives. Ethical approval 
      was obtained from the London-Bloomsbury Research Ethics Committee, UK. The study 
      is sponsored by University College London, UK. DISCUSSION: This study compares a 
      comprehensive and robust range of clinical, functional, and radiological outcomes 
      in CO UKA versus RO UKA. The findings of this study will provide an improved 
      understanding of the differences in CO UKA versus RO UKA with respect to accuracy 
      of implant positioning, patient satisfaction, functional outcomes, implant 
      survivorship, cost-effectiveness, and complications. TRIAL REGISTRATION: 
      ClinicalTrials.gov NCT04095637 . Registered on 19 September 2019.
FAU - Kayani, Babar
AU  - Kayani B
AUID- ORCID: 0000-0001-6611-3989
AD  - Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 
      Euston Road, Fitzrovia, London, NW1 2BU, UK. babar.kayani@gmail.com.
FAU - Konan, Sujith
AU  - Konan S
AD  - Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 
      Euston Road, Fitzrovia, London, NW1 2BU, UK.
FAU - Tahmassebi, Jenni
AU  - Tahmassebi J
AD  - Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 
      Euston Road, Fitzrovia, London, NW1 2BU, UK.
FAU - Ayuob, Atif
AU  - Ayuob A
AD  - Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 
      Euston Road, Fitzrovia, London, NW1 2BU, UK.
FAU - Moriarty, Peter D
AU  - Moriarty PD
AD  - Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 
      Euston Road, Fitzrovia, London, NW1 2BU, UK.
FAU - Haddad, Fares S
AU  - Haddad FS
AD  - Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 
      Euston Road, Fitzrovia, London, NW1 2BU, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT04095637
GR  - 25009/Stryker/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20200817
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Arthroplasty, Replacement, Knee/*methods
MH  - Humans
MH  - Knee Joint/diagnostic imaging/surgery
MH  - London
MH  - Middle Aged
MH  - *Osteoarthritis, Knee/surgery
MH  - Prospective Studies
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - *Robotic Surgical Procedures
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC7430022
COIS- FSH reports board membership of the Bone and Joint Journal and the Annals of the 
      Royal College of Surgeons; consultancy for Smith & Nephew, Corin, MatOrtho and 
      Stryker; payment for lectures including service on speakers' bureaus for Smith & 
      Nephew and Stryker; and royalties paid by Smith & Nephew, MatOrtho, Corin and 
      Stryker, all outside the submitted work. SK reports consultancy, payment for 
      lectures including service on speakers' bureaus, payment for development of 
      education presentations, and travel/accommodations/ meeting expenses for Smith 
      and Nephew and AO, all outside the submitted work. All other authors declare no 
      competing interests.
EDAT- 2020/08/19 06:00
MHDA- 2021/05/28 06:00
PMCR- 2020/08/17
CRDT- 2020/08/19 06:00
PHST- 2020/03/03 00:00 [received]
PHST- 2020/07/26 00:00 [accepted]
PHST- 2020/08/19 06:00 [entrez]
PHST- 2020/08/19 06:00 [pubmed]
PHST- 2021/05/28 06:00 [medline]
PHST- 2020/08/17 00:00 [pmc-release]
AID - 10.1186/s13063-020-04631-5 [pii]
AID - 4631 [pii]
AID - 10.1186/s13063-020-04631-5 [doi]
PST - epublish
SO  - Trials. 2020 Aug 17;21(1):721. doi: 10.1186/s13063-020-04631-5.