Monocer AOANJRR Registry-nested Study

Prospective, Multicentre Study to Assess Performance of the Mpact 3D Metal MonoCer Cup Implant in Primary Total Hip Replacement

This study titled "Prospective, Multicentre Study to Assess Performance of the MonoCer Acetabular Cup in Primary Total Hip Replacement" is a multi-centre prospective registry-nested cohort study, using AOANJRR's web-based data collection system integrated with Registry data collection, designed to assess the ten-year clinical outcome of the MonoCer Acetabular Cup in Primary Total Hip Replacement. The primary outcome measure is mortality and secondary measures are PROMs and complications.

Study Overview

• Status: Recruiting
• Conditions: Survival, Prosthesis

Detailed Description

This study titled "Prospective, Multicentre Study to Assess Performance of the MonoCer Acetabular Cup in Primary Total Hip Replacement" is a multi-centre prospective registry-nested cohort study, using AOANJRR's web-based data collection system integrated with Registry data collection, designed to assess the ten-year clinical outcome of the MonoCer Acetabular Cup in Primary Total Hip Replacement. The primary outcome measure is mortality and secondary measures are PROMs and complications.

The purpose and objectives of this study are to assess and document the clinical outcomes in a group of primary total hip arthroplasty patients having this surgery for the management of end-stage osteoarthritis. Survivorship and changes in pain and function as well as death will be assessed. The design of this study will also allow, if required the continued follow-up after the initial 2 years to determine mid and long-term survivorship and performance of this cohort.

All patients will receive primary hip arthroplasty standard of care (pre and post operatively) as defined by each participating surgeon. In addition to the Medacta MonoCer Acetabular Cup. There shall be no investigational, experimental or "off-label" use of the device. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labelling.

A prospective study will be conducted using the AOANJRR web-based data collection system (RAPID). Eligible and consented participants are registered in the RAPID system. The PROMs will be completed by patients via the RAPID system.

• Surgeons will determine patient eligibility, providing informed consent prior to enrolment and registration in RAPID.

Participating sites will send procedure data to the AOANJRR as per standard practice, this data is then linked to the study participant. All data will be stored in a secure data repository.

• A minimum of 280 patients will be recruited over an 18-month period.
• All data will be integrated with routinely collected Registry data.

• Study Type: Observational
• Enrollment (Anticipated): 280

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Recruiting
    • Melbourne Orthopaedic Group
    • Contact: Jit Balakumar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

At least 280 patients will be recruited who will have the Mpact 3D Metal MonoCer acetabular cup prosthesis from four surgeons in Australia.

Description

Inclusion Criteria:

• Patients undergoing a primary total conventional hip replacement and are suitable for cementless acetabular cup according to the indications for use (On-label use).
• Use of the Medacta Mpact 3D Metal MonoCer acetabular cup prosthesis.
• Adults aged between 18 and 75 years at the time of registration.
• Ability to give informed consent.
• Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.

Exclusion Criteria:

Exclusion Criteria

• Rheumatoid arthritis.
• Patients with a history of active infection.
• Any case not described in the inclusion criteria.
• Revision procedures.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates.	Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.	2 years
Survival rate at 5 years compared to all other acetabular cups utilising AOANJRR data revision rates.	Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.	5 years
Survival rate at 10 years compared to all other acetabular cups utilising AOANJRR data revision rates.	Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates. Analysis of reasons for revisions.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with EQ-5D-5L	Assessments / Questionnaires (Patient Reported Outcome Measures) EQ-5D-5L (EuroQol) min=0 (worst score) max=100 (best score) The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	pre-op, 6 months, 1 year, 2 years, 5 years, 10 years
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with OHS	Assessments / Questionnaires (Patient Reported Outcome Measures) OHS The OHS is a short 12-item survey that can be done with pen and paper, or online. Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.	pre-op,6 months, 1 year, 2 years, 5 years, 10 years
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with HOOS	Assessments / Questionnaires (Patient Reported Outcome Measures): HOOS HOOS: The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process. The HOOS questionnaire is a patient-administered self-report questionnaire and takes 7 to 10 minutes to complete. It is designed to be self-explanatory and user-friendly[1]. The HOOS includes 40 items with five possible responses, graded from 0 to 4 (0 points = worst possible score; 100 points = best possible score).	pre-op,6 months, 1 year, 2 years, 5 years, 10 years
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with MONA	Assessments / Questionnaires (Patient Reported Outcome Measures): MONA (Melbourne Orthopaedic Noise assesment) MONA questionnaire, which has a high sensitivity for the detection of noises, concerning noise frequency and the quality of noise. Patients were asked if any noise had been heard from their hip joint at any time after surgery.	6 months, 1 year, 2 years, 5 years, 10 years
Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with VAS	Assessments / Questionnaires (Patient Reported Outcome Measures): VAS (Visual Analog Scale) from 0 (worst) to 100 (best) score. The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between paints with similar conditions.	pre-op,6 months, 1 year, 2 years, 5 years, 10 years

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Jit Balakumar, Melbourne Orthopaedic Group

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2021
• Primary Completion (Anticipated): January 1, 2031
• Study Completion (Anticipated): June 1, 2032

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: P01.026.001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No