NCT03846791

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

4.8 years

First QC Date

February 13, 2019

Last Update Submit

August 12, 2024

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (18)

  • Accuracy of component positioning

    1 Year post surgery

  • Functional Assessments - Chair stand

    1 Year post surgery

  • Functional Assessments - Fast paced Walk

    1 Year post surgery

  • Functional Assessments - Stair Climb

    1 Year post surgery

  • Gait analysis

    1 Year post surgery

  • +13 more secondary outcomes

Interventions

Observational Study Post MAKO Robotic SurgeryOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing Robot Assisted Total Hip Replacement at the Nuffield Health

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nuffield Health Bournemouth

Bournemouth, BH1 1RW, United Kingdom

Location

Orthopaedic Research Institute Bournemouth University

Bournemouth, BH8 8FT, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Tom Wainwright

    Professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 20, 2019

Study Start

July 15, 2019

Primary Completion

May 3, 2024

Study Completion

May 3, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)