An Evaluation of Health Outcomes for Mako Hip Replacement

Osteoarthritis, Hip Clinical Trial

— HELLO  

Official title:

An Evaluation of Health Outcomes for Mako Hip Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03846791
• Other study ID #: ORI/Mako/18
• Status: Recruiting
• Start date: July 15, 2019
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Bournemouth University
• Contact: Julie Northam
• Phone: 012029
• Email: jnortham[@]bournemouth.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Other:
• Observational Study Post MAKO Robotic Surgery
To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement surgery using the MAKO robot

Locations

Country	Name	City	State
United Kingdom	Nuffield Health Bournemouth	Bournemouth
United Kingdom	Orthopaedic Research Institute Bournemouth University	Bournemouth

Sponsors (4)

Lead Sponsor	Collaborator
Bournemouth University	Nuffield Health Bournemouth, Orthopaedic Research Institute, Stryker Orthopaedics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Accuracy of component positioning	Placement of prosthetic components will be evaluated by assessing radiographs	1 Year post surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Measurement of pre-operative psoas muscle mass	This measurement will be taken from the pre-surgery CT scan	Pre-Operative
Secondary	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
Secondary	Patient Reported Outcome Measures - The Pain Catastrophizing Score (PCS)	The Pain Catastrophizing Score (PCS) will be assessed prior to surgery.	Pre-Operative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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