Clinical trial NCT05822505: Monocer AOANJRR Registry-nested Study
Official title: Prospective, Multicentre Study to Assess Performance of the Mpact 3D Metal MonoCer Cup Implant in Primary Total Hip Replacement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Survival, Prosthesis
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates.
timeFrame: 2 years
measure: Survival rate at 5 years compared to all other acetabular cups utilising AOANJRR data revision rates.
timeFrame: 5 years
measure: Survival rate at 10 years compared to all other acetabular cups utilising AOANJRR data revision rates.
timeFrame: 10 years
Secondary outcomes:
measure: Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with EQ-5D-5L
timeFrame: pre-op, 6 months, 1 year, 2 years, 5 years, 10 years
measure: Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with OHS
timeFrame: pre-op,6 months, 1 year, 2 years, 5 years, 10 years
measure: Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with HOOS
timeFrame: pre-op,6 months, 1 year, 2 years, 5 years, 10 years
measure: Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with MONA
timeFrame: 6 months, 1 year, 2 years, 5 years, 10 years
measure: Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with VAS
timeFrame: pre-op,6 months, 1 year, 2 years, 5 years, 10 years
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Melbourne Orthopaedic Group
Study officials:
affiliation: Melbourne Orthopaedic Group
name: Jit Balakumar
role: PRINCIPAL_INVESTIGATOR
References: