Clinical trial NCT04095845: Conventional Total Hip Arthroplasty vs Mako Robotic-arm Assisted Total Hip Arthroplasty
Official title: A Prospective Randomised Controlled Trial Comparing Computerised Tomography Based Planning of Conventional Total Hip Arthroplasty Versus Mako Robotic-arm Assisted Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Hip
Osteoarthritis
Surgery
Keywords: total hip arthroplasty
total hip replacement
implant position
computerised tomography
makoplasty
robotic surgery
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Stryker Instruments
First posted: 2019-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of this single-centre, prospective randomised controlled trial is to compare clinical, functional, and radiological outcomes in CO THA versus Mako THA. Patients undergoing Mako THA will form the investigation group and those undergoing CO THA will form the control group.


Eligibility criteria: Inclusion Criteria:

* Patient has hip osteoarthritis requiring primary THA

  * Patient and surgeon are in agreement that THA is the most appropriate treatment
  * Patient is fit for surgical intervention following review by surgeon and anaesthetist
  * Patient age: Patients 18-80 years of age inclusive
  * Gender: male and female
  * Patient must be capable of giving informed consent and agree to comply with the postoperative review program
  * Patient must be a permanent resident in an area accessible to the study site
  * Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken

Exclusion Criteria:

* Patient is not suitable for primary THA e.g. patient requires revision surgery for previously failed THA

  * Patient is not medically fit for surgical intervention
  * Patients under the age of 18 or over 80 years of age
  * Patient is immobile or has another neurological condition affecting musculoskeletal function
  * Patient is already enrolled on another concurrent clinical trial
  * Patient is unable or unwilling to sign the informed consent form specific to this study
  * Patient lacks capacity to give informed consent
  * Patient is unable to attend the follow-up programme
  * Patient is non-resident in local area or expected to leave the catchment area postoperatively

Primary outcomes:
measure: Reproducibility of the planned pre-operative centre of rotation [COR] of the hip
timeFrame: 6 weeks post-op
Secondary outcomes:
measure: Spinopelvic alignment
timeFrame: Preoperatively and postoperatively at 6 months
measure: Operating time
timeFrame: Intraoperative
measure: Blood loss
timeFrame: Intraoperative
measure: Blood transfusion requirements
timeFrame: Intraoperative
measure: Bone resection thickness
timeFrame: Intraoperative
measure: Length of hospital stay
timeFrame: 6 weeks post op
measure: Oxford hip score [OHS]
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Harris Hip Score [HHS]
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Western Ontario and Mcmaster Universities Osteoarthritis Index [WOMAC]
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: University of California at Los Angeles hip [UCLA]
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: European Quality of Life questionnaire with 5 dimensions for adults [EQ-5D]
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Complications
timeFrame: Intraoperative; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL Hospital NHS Foundation Trust
Study officials:
affiliation: UCL Hospital NHS Foundation Trust
name: Fares S Haddad
role: STUDY_CHAIR
affiliation: UCL Hospitals NHS Foundation TRust
name: Babar Kayani
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kayani B, Konan S, Tahmassebi J, Ayuob A, Haddad FS. Computerised tomography-based planning with conventional total hip arthroplasty versus robotic-arm assisted total hip arthroplasty: study protocol for a prospective randomised controlled trial. Trials. 2020 Sep 10;21(1):776. doi: 10.1186/s13063-020-04702-7.