A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement
NCT ID: NCT05507073
Last Updated: 2023-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-04-06
2024-12-30
Brief Summary
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Detailed Description
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Arm 1: Manual total hip replacement with conventional templating Arm 2: Robotic total hip replacement In the study 25 participants will receive manual THR with conventional templating; the other 25 will receive Robotic THR.
Following recruitment in outpatient clinics, participants will undergo baseline assessments, including imaging and clinical assessment. All participants will then undergo THR surgery, which will likely entail an inpatient hospital stay of 1-2 days. Post-operative rehabilitation will be in line with the normal standard care for all participants. Post-operatively participants will make two visits to clinic at 6 weeks and 12 months (standard of care).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Manual Total Hip Replacement
Manual Total Hip Replacement
Manual Total Hip Replacement
Implantation of a hip Device to alleviate pain and recover range of movement
Robot-Assisted Total Hip Replacement
Robot-Assisted Total Hip Replacement
Robot-Assisted Total Hip Replacement
Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement
Interventions
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Manual Total Hip Replacement
Implantation of a hip Device to alleviate pain and recover range of movement
Robot-Assisted Total Hip Replacement
Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or Female, aged 18 to 85 years at recruitment into trial
* Diagnosed with hip OA, post-traumatic OA, inflammatory arthropathy, , or congenital or developmental hip disease, avascular necrosis of the hip
* Listed for total hip replacement
* Suitable for Accolade 2 stem and Trident cup prostheses
* Female participants of child bearing potential must be willing to ensure that they use effective contraception during the trial
* In the Investigator's opinion, is able and willing to comply with all trial requirements
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Exclusion Criteria
* Previous surgery to the ipsilateral hip and implantation of metalwork.
* Significant co-morbidities that would make follow up difficult or uncomfortable
* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
* Pregnancy or intention to become pregnant within the trial period.
18 Years
ALL
No
Sponsors
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Stryker Nordic
INDUSTRY
The Royal Orthopaedic Hospital NHS Trust
OTHER
Responsible Party
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Locations
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The Royal Orthopaedic Hospital NHS Trust
Birmingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ROH20ORTH16
Identifier Type: -
Identifier Source: org_study_id
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