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

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ClinicalTrials.gov Identifier: NCT03846791
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
Nuffield Health Bournemouth
Orthopaedic Research Institute
Stryker Orthopaedics
Information provided by (Responsible Party):
Bournemouth University

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

Condition or disease Intervention/treatment
Osteoarthritis, Hip Other: Observational Study Post MAKO Robotic Surgery

Detailed Description:

This is an observational cohort study. It evaluates the recovery of 100 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 also 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. These visits are in addition to the routine clinical follow-up visits at Nuffield Hospital.

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of Health Outcomes for Mako Hip Replacement
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement


Intervention Details:
  • 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


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

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


Secondary Outcome Measures :
  1. Accuracy of component positioning [ Time Frame: 1 Year ]
    Placement of prosthetic components will be evaluated by assessing radiographs

  2. Functional Assessments - Chair stand [ Time Frame: 1 Year ]
    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

  3. Functional Assessments - Fast paced Walk [ Time Frame: 1 Year ]
    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

  4. Functional Assessments - Stair Climb [ Time Frame: 1 Year ]
    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

  5. Gait analysis [ Time Frame: 1 Year ]
    Participants' gait will be analysed using the GRAIL MotekForce at 6-8 weeks, 3 months, 6 months and 1 year following surgery.

  6. Muscle Testing [ Time Frame: 1 Year ]
    Participants' muscle strength will be analysed using the Primus BTE at 6-8 weeks, 3 months, 6 months and 1 year following surgery.

  7. Measurement of pre-operative psoas muscle mass [ Time Frame: Pre-Operative ]
    This measurement will be taken from the pre-surgery CT scan

  8. Patient Reported Outcome Measures - EQ-5D Quality of Life Score [ Time Frame: 6 Months ]
    EQ-5D Quality of Life Score will be assessed at pre-surgery and at 6 months.

  9. Patient Reported Outcome Measures - The Pain Catastrophizing Score (PCS) [ Time Frame: Pre-Operative ]
    The Pain Catastrophizing Score (PCS) will be assessed prior to surgery.

  10. Patient Reported Outcome Measures - The Hip Disability and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 1 Year ]
    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

  11. Surgery related resource use - length of stay in hospital [ Time Frame: 1 Year ]
    Data will be reported on surgery-related use of resources for length of stay in hospital

  12. Surgery related resource use - time in theatre [ Time Frame: 1 Year ]
    Data will be reported on surgery-related use of resources for time in theatre

  13. Surgery related resource use - unplanned hospital visits [ Time Frame: 1 Year ]
    Data will be reported on surgery-related use of resources for unplanned hospital visits

  14. Surgery related resource use - non-routine medication [ Time Frame: 1 Year ]
    Data will be reported on surgery-related use of resources for non-routine medication

  15. Surgery related resource use - number of outpatient appointments [ Time Frame: 1 Year ]
    Data will be reported on surgery-related use of resources for number of outpatient appointments

  16. Surgery related resource use - number of physiotherapy appointments [ Time Frame: 1 Year ]
    Data will be reported on surgery-related use of resources for number of physiotherapy appointments.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing Robot Assisted Total Hip Replacement at the Nuffield Health
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846791


Contacts
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Contact: Julie Northam 012029 ext 61208 jnortham@bournemouth.ac.uk
Contact: Suzy Wignall 012029 ext 61073 swignall@bournemouth.ac.uk

Locations
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United Kingdom
Nuffield Health Bournemouth Not yet recruiting
Bournemouth, United Kingdom, BH1 1RW
Contact: Francesco Ferraro         
Contact       fferraro@bournemouth.ac.uk   
Orthopaedic Research Institute Bournemouth University Recruiting
Bournemouth, United Kingdom, BH8 8FT
Contact: Tom Wainwright         
Contact: Tikki Immins         
Sub-Investigator: Francesco Ferraro         
Principal Investigator: Tom Wainwright         
Sponsors and Collaborators
Bournemouth University
Nuffield Health Bournemouth
Orthopaedic Research Institute
Stryker Orthopaedics
Investigators
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Study Director: Tom Wainwright Associate Professor

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Responsible Party: Bournemouth University
ClinicalTrials.gov Identifier: NCT03846791     History of Changes
Other Study ID Numbers: ORI/Mako/18
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases