An Evaluation of Health Outcomes for Mako Hip Replacement (HELLO)

To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement using the Mako Robo

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Other: Observational Study Post MAKO Robotic Surgery

Detailed Description

This is an observational cohort study. It evaluates the recovery of 200 patients who are having routine robotic hip replacement surgery at a Nuffield Hospital in Bournemouth. Any complications from the surgery, or readmissions to hospital, will be reported. Investigators will measure how accurately the surgeon, assisted by the robotic-arm, positions the hip implant during the surgery using x-rays taken as part of routine care. The study also monitors the progress of rehabilitation by assessing pain and functional ability in the year following surgery, and will investigate whether there is an association between this recovery and a measurement of an area of muscle in the pelvic region, taken from a routine CT scan.

Patients will be asked to come to the Orthopaedic Research Institute at Bournemouth University to be assessed before they have surgery, and again at 3 weeks, 6-8 weeks, 3 months, 6 months and 12 months following surgery. At these visits they will be asked about their pain, how well they can do daily activities, and their quality of life. They will be assessed on their ability to sit-to-stand five times, walk for 40m, and climb some stairs. At each visit, except the three weeks visit, they will also have their gait tested on a specialised clinical treadmill, and the muscle strength in their legs measured. They will also be measured for oedema at baseline, 3 weeks and 6-8 weeks using a Fit3D ProScanner. These visits are in addition to the routine clinical follow-up visits at Nuffield Hospital. Participants will also be invited to wear a wrist activity monitor for at least three consecutive days prior to surgery and for the 6 weeks following discharge so that their activity can be recorded.

Surgery-related resource use of the procedure will also be reported, such as length of hospital stay, time in theatre, unplanned hospital visits, non-routine medication, outpatient appointments and physiotherapy appointments.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Julie Northam; Phone Number: 61208 012029; Email: jnortham@bournemouth.ac.uk
• Study Contact Backup: Name: Suzy Wignall; Phone Number: 61073 012029; Email: swignall@bournemouth.ac.uk

Study Locations

• United Kingdom
  • Bournemouth, United Kingdom, BH1 1RW
    • Recruiting
    • Nuffield Health Bournemouth
    • Contact: Rob Middleton
    • Contact: Email: rmiddleton@bournemouth.ac.uk
  • Bournemouth, United Kingdom, BH8 8FT
    • Active, not recruiting
    • Orthopaedic Research Institute Bournemouth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing Robot Assisted Total Hip Replacement at the Nuffield Health

Description

Inclusion Criteria:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, suitable for unilateral primary hip replacement;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Voluntary written Informed Consent obtained.
• Participant able to complete study follow-up.

Exclusion Criteria:

• Prospect for recovery to independent mobility compromised by known coexistent medical problems;
• Requiring revision hip replacement;
• Previous hip replacement (resurfacing or THR) on the contralateral side, with outcome achieving an Oxford Hip score <18 points;
• Likely post-operative leg length inequality >5cm;
• Neuromuscular disease affecting hip (Parkinson's, cerebral palsy, other spasticity);
• Primary or metastatic tumor involving this hip;
• Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
• Previous arthrodesis or excision arthroplasty
• Acetabular deficiency - >2cm superior loss acetabular dome or >1.5cm protrusion acetabulae or wall deficiency> half a wall;
• Dysplasia (DDH) with >2.5cm subluxation or complete dislocation;
• Body mass index > 40kg/m2;
• Active or previous or suspected infection in this hip;
• Sepsis or osteomyelitis;
• Known sensitivity to device materials;
• Not physically able to use Grail gait lab and Primus muscle testing equipment;
• Women judged by the Investigator to be of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period;
• Unable to provide informed consent (insufficient English, cognitive disorder such as dementia, psychiatric illness);
• Unable to complete follow-ups (life expectancy <5 years, insufficient English, lives overseas, unable to return easily).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The measurement of surgical complications post surgery	This study's primary outcome is to report on surgical complications. Events will be sub-classified as device (prosthesis or robot) or surgeon related.	1 Year post surgery
The measurement of readmission post surgery	This study's primary outcome is to report on surgical complications. Events will be sub-classified as device (prosthesis or robot) or surgeon related.	1 Year post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of component positioning	Placement of prosthetic components will be evaluated by assessing radiographs	1 Year post surgery
Functional Assessments - Chair stand	30 s Chair Stand test as recommended by the Osteoarthritis Research Society International (OARSI). Assessment will be done prior to surgery, and again at 3 weeks, 6-8 weeks, 3 months, 6 months and 1 year following surgery	1 Year post surgery
Functional Assessments - Fast paced Walk	40m fast-paced walk test as recommended by the Osteoarthritis Research Society International (OARSI). Assessment will be done prior to surgery, and again at 3 weeks, 6-8 weeks, 3 months, 6 months and 1 year following surgery	1 Year post surgery
Functional Assessments - Stair Climb	Stair climb test as recommended by the Osteoarthritis Research Society International (OARSI). Assessment will be done prior to surgery, and again at 3 weeks, 6-8 weeks, 3 months, 6 months and 1 year following surgery	1 Year post surgery
Gait analysis	Participants' gait will be analysed using the GRAIL MotekForce at baseline, 6-8 weeks, 3 months, 6 months and 1 year following surgery.	1 Year post surgery
Muscle Testing	Participants' muscle strength will be analysed using the Primus BTE at baseline, 6-8 weeks, 3 months, 6 months and 1 year following surgery.	1 Year post surgery
Measurement of pre-operative psoas muscle mass	This measurement will be taken from the pre-surgery CT scan	Pre-Operative
Patient Reported Outcome Measures - EQ-5D Quality of Life Score	EQ-5D Quality of Life Score will be assessed at pre-surgery and at 6 months.	6 Months post surgery
Patient Reported Outcome Measures - The Pain Catastrophizing Score (PCS)	The Pain Catastrophizing Score (PCS) will be assessed prior to surgery.	Pre-Operative
Patient Reported Outcome Measures - The Hip Disability and Osteoarthritis Outcome Score (HOOS)	The Hip Disability and Osteoarthritis Outcome Score (HOOS) will be assessed at pre-surgery, 3 weeks, 6-8 weeks, 3 month, 6 months and 1 year following surgery	1 Year post surgery
Surgery related resource use - length of stay in hospital	Data will be reported on surgery-related use of resources for length of stay in hospital	1 Year post surgery
Surgery related resource use - time in theatre	Data will be reported on surgery-related use of resources for time in theatre	1 Year post surgery
Surgery related resource use - unplanned hospital visits	Data will be reported on surgery-related use of resources for unplanned hospital visits	1 Year post surgery
Surgery related resource use - non-routine medication	Data will be reported on surgery-related use of resources for non-routine medication	1 Year post surgery
Surgery related resource use - number of outpatient appointments	Data will be reported on surgery-related use of resources for number of outpatient appointments	1 Year post surgery
Surgery related resource use - number of physiotherapy appointments	Data will be reported on surgery-related use of resources for number of physiotherapy appointments.	1 Year post surgery
Monitoring of physical activity	Participants will be invited to wear an activity monitor on their wrist for at least three consecutive days prior to surgery, and for the 6-8 weeks following discharge	6-8 weeks following surgery
Measurement of oedema	Participants will be assessed for oedema using a Fit3D ProScanner at baseline, 3 weeks and 6-8 weeks following surgery.	6-8 weeks following surgery

Collaborators and Investigators

• Sponsor: Bournemouth University
• Collaborators: Stryker Orthopaedics; Nuffield Health Bournemouth; Orthopaedic Research Institute
• Investigators: Study Director: Tom Wainwright, Professor

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: ORI/Mako/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No