The Hip Arthroplasty Positioning Improvement Study

NCT03560063 | Unknown DMC

• 1 other identifier: IRAS 216084
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine whether the Corin Optimised Positioning System (Corin, U.K.) reduces the rate of hip dislocation at one-year post-operatively compared with standard templating in patients undergoing total hip replacement. The secondary objectives of this study are to determine whether the Corin Optimised Positioning System (Corin, U.K.) improves functional outcomes, reduces length of hospital stay, and reduces leg length discrepancy compared with standard templating in patients undergoing total hip replacement.

Conditions

Osteoarthritis, Hip; Osteoarthritis; Arthritis; Musculoskeletal Diseases or Conditions

Keywords

arthroplasty; dislocation; templating

Outcome Measures

Primary Outcomes (1)

• Dislocation rate

  Incidence of hip dislocation within 12 months post-operatively

  12 months

Secondary Outcomes (10)

• Change in Harris Hip Score

  Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively

• Change in Oxford Hip Score

  Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively

• Change in Hip and Groin Outcome Score

  Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively

• Change in International Hip Outcome Tool 33 (iHOT33) Score

  Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively

• Change in EuroQol 5 dimension (EQ5D) Score

  Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively

Study Arms (2)

Corin OPS arm

EXPERIMENTAL

Total hip replacement with use of Corin Optimised Positioning System to guide implant positioning

Procedure: Corin Optimised Positioning System

Standard care arm

ACTIVE COMPARATOR

Total hip replacement with standard templating to guide implant positioning

Procedure: Standard templating

Interventions

Corin Optimised Positioning System PROCEDURE

Total hip replacement with implant positioning guided by Corin Optimised Positioning System. The experimental and active comparator arms will use the same implants for total hip replacements. The Corin Trinity shell system will be used for the acetabular system. The Corin MiniHip, TriFit, MetaFix and TaperFit implants will be used for the femoral stem implant. Surgeons will select the implant most appropriate for each patient.

Also known as: K171847

Corin OPS arm

Standard templating PROCEDURE

Total hip replacement with implant positioning guided by standard templating. The experimental and active comparator arms will use the same implants for total hip replacements. The Corin Trinity shell system will be used for the acetabular system. The Corin MiniHip, TriFit, MetaFix and TaperFit implants will be used for the femoral stem implant. Surgeons will select the implant most appropriate for each patient.

Also known as: Anteroposterior and lateral hip radiographs

Standard care arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the trial
• Diagnosed with hip OA, post-traumatic OA, inflammatory arthropathy, avascular necrosis, or congenital or developmental hip disease, avascular necrosis of the hip
• Listed for total hip arthroplasty at one of participating centres
• Participant is fit to undergo total hip arthroplasty based on consultant anaesthetist review
• 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
• Female participants of child bearing potential must be willing to ensure that they use effective contraception during the trial

You may not qualify if:

• Inability to provide informed consent
• Previous surgery to the ipsilateral hip
• Significant co-morbidities that would make follow up difficult or uncomfortable
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
• Pregnancy

Sponsors & Collaborators

• University of Oxford: lead
• Corin: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

Nuffield Orthopaedic Centre, Oxford University Hospitals Trust

Oxford, OX3 7LD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis; Arthritis; Musculoskeletal Diseases; Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Rheumatic Diseases; Wounds and Injuries

Study Officials

• Sion Glyn-Jones, DPhil FRCS

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marian Montgomery

CONTACT

+44 1865 737262; hapi@ndorms.ox.ac.uk

Pam Lovegrove

CONTACT

+44 1865 227803; pam.lovegrove@ndorms.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants: participants in both arms will undergo total hip replacement while under general anaesthetic. Participants will not be aware of the templating method used during the total hip replacement due to the general anaesthetic, therefore will remain blinded. Wounds and dressings will be the same for both study arms. Participants in the two study arms will undergo the same pre- and post-operative imaging to prevent unmasking. Outcomes assessors examine patients from 3 months post-operatively. There is no risk they will know which arm the patient is in, as they will not have access to the study database.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be recruited and randomised into the two parallel study arms. Interventional arm: total hip replacement with use of the Corin Optimised Positioning System to guide templating. Comparator arm: total hip replacement, guided by standard templating techniques

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 18, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: March 29, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by the trial steering committee. Requestors will be required to sign a data access agreement

Locations

GB (1)