A Comparison of Impingement Free Range of Motion With CT... | NCT05507073

Studies
A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement

NCT05507073

Sponsor

The Royal Orthopaedic Hospital NHS Trust

Status

Unknown status

Last Update Posted

Sep 8, 2023Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

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

Interventions

Manual Total Hip Replacement
Robot-Assisted Total Hip Replacement

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2021Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Jun 27, 2022

First Submission Date that Met QC Criteria

Aug 17, 2022

First Posted Date

Aug 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2023

Last Update Posted Date

Sep 8, 2023Actual

Name	Class
Stryker Nordic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Manual Total Hip Replacement	Active Comparator	Manual Total Hip Replacement	Procedure: Manual Total Hip Replacement
Robot-Assisted Total Hip Replacement	Experimental	Robot-Assisted Total Hip Replacement	Procedure: Robot-Assisted Total Hip Replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Manual Total Hip Replacement	Procedure	Implantation of a hip Device to alleviate pain and recover range of movement	Manual Total Hip Replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR	To compare efficacy of Robotic THR in reducing post-operative impingement with Standard Manual THR	6 weeks post-intervention

Secondary Outcomes

Measure	Description	Time Frame
Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures	To determine whether the Robotic THR improves patient reported outcome measures	12 months
Using the Oxford Hip score to determine improvement in Patient reported outcome measures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Edward T Davis, MD	Contact	01216854000	55306	edward.davis@nhs.net
Sam C Papadopoullos, BSc	Contact	01216854000	55306	sam.papadopoullos@nhs.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Royal Orthopaedic Hospital NHS Trust	Recruiting	Birmingham			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

ID	Term
D015207	Osteoarthritis, Hip
D001168	Arthritis

ID	Term
D010003	Osteoarthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures
D019919	Prosthesis Implantation