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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2024-12-30

Brief Summary

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Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants.

Detailed Description

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This will be a two-arm, single blind (assessor blind), randomised controlled group study. It will take place in the NHS hospital setting. Stratification will be performed for age and sex by means of a minimisation technique during randomisation for each subject entering the trial.

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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Hip Osteoarthritis Post-traumatic Osteoarthritis Inflammatory Arthritis Congenital Hip Problems Avascular Necrosis of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a two-arm, single blind (assessor blind), randomised controlled group study. It will take place in the NHS hospital setting. Stratification will be performed for age and sex by means of a minimisation technique during randomisation for each subject entering the trial. Any participant that withdraws from the study will be replaced.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Individual/s carrying out assessment post-intervention are not aware of the intervention allocation

Study Groups

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Manual Total Hip Replacement

Manual Total Hip Replacement

Group Type ACTIVE_COMPARATOR

Manual Total Hip Replacement

Intervention Type PROCEDURE

Implantation of a hip Device to alleviate pain and recover range of movement

Robot-Assisted Total Hip Replacement

Robot-Assisted Total Hip Replacement

Group Type EXPERIMENTAL

Robot-Assisted Total Hip Replacement

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Robot-Assisted Total Hip Replacement

Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement

Intervention Type PROCEDURE

Other Intervention Names

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Hip Arthroplasty Hip Replacement Total Hip Replacement Hip replacement Robotic Hip replacement Robot Assisted Hip Arthroplasty

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the trial
* 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

* Inability to provide informed consent
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Nordic

INDUSTRY

Sponsor Role collaborator

The Royal Orthopaedic Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Royal Orthopaedic Hospital NHS Trust

Birmingham, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Edward T Davis, MD

Role: CONTACT

01216854000 ext. 55306

Sam C Papadopoullos, BSc

Role: CONTACT

01216854000 ext. 55306

Facility Contacts

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Gareth Stephens

Role: primary

01216854120

Other Identifiers

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ROH20ORTH16

Identifier Type: -

Identifier Source: org_study_id

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