The purpose of this clinical study is to evaluate a multitude of factors that may influence clinical outcomes when performing primary reverse shoulder arthroplasty (RSA) with the Exactech Guided Personalized Surgery (GPS , Exactech, Gainesville, FL…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Alignment of the prosthesis (i.e., degree of accurate implant placement
according to plan, using a postoperative CT scan to confirm position).
Secondary outcome
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
Form and range of motion measurements at 3 months, 1 year, 2- year, 5-year, and
10-year postoperative timepoints.
Radiographic outcomes from scans (e.g., radiolucent lines, notching, etc.)
Background summary
It is hypothesised that patients receiving a primary reverse shoulder
arthroplasty will have better shoulder alignment in terms of glenoid implant
placement in mm and angulation (version and inclination) with respect to the
preoperative plan with the GPS technique compared to the conventional technique.
Furthermore, it is hypothesised that patients receiving a primary reverse
shoulder arthroplastywill demonstrate better patient reported outcomes (ASES)
and ROM measurements (e.g. active abduction and active forward flexion) with
the GPS technique compared to the conventional technique.
Study objective
The purpose of this clinical study is to evaluate a multitude of factors that
may influence clinical outcomes when performing primary reverse shoulder
arthroplasty (RSA) with the Exactech Guided Personalized Surgery (GPS ,
Exactech, Gainesville, FL) compared to conventional instrumentation.
Study design
This is a prospective, multi-center, clinical study with three phases: 1)
Non-Randomized Conventional Cohort, 2) Exactech GPS Training Cohort, and 3)
Randomized Cohorts.
1) Non-Randomized Conventional Cohort, 2) GPS Training Cohort, 3) Randomized
Cohorts
Each surgeon investigator will participate in all three phases with the same
shoulder system. In order to benchmark their conventional technique, the
Non-Randomized Conventional Cohort, each surgeon will conduct 10 consecutive
cases using their conventional technique. Next, to learn the Exactech GPS®
system, GPS Training Cohort, each surgeon will conduct 10 consecutive cases
using the GPS technique. Once Phase 1 and Phase 2 are completed, the surgeon
can progress to the Randomized Cohorts, Phase 3.
Intervention
Implantation of Equinoxe® Shoulder System.
Since patients enrolled in this study will only have reverse shoulder
arthroplasty surgery, only reverse shoulder components will be used.
In one study arm, the Exactech GPS® will be used. Exactech GPS® is a navigation
system used for implantation of Exactech shoulder prostheses.
In the second study arm, conventional instrumentation will be used.
Study burden and risks
Within the framework of the study, an additional CT scan will be performed. A
CT scan exposes the subject to radiation. The total radiation dose from a CT
scan is about three times the amount of radiation the subject is normally
exposed to in one year ("background radiation").
NW 66th Court 2320
Gainesville, Florida 32653 32653
US
NW 66th Court 2320
Gainesville, Florida 32653 32653
US
Listed location countries
Age
Inclusion criteria
Patient is at least 21 years of age at the time of surgery.
Patient is indicated for reverse shoulder arthroplasty.
Patient is willing to participate by complying with pre- and postoperative
visit requirements.
Patient is willing to participate for the entire length of the prescribed
follow-up (minimum 2 years).
Patient is willing and able to review and sign a study informed consent form.
Preop CT scan is within 3 months of the date of surgery.
Exclusion criteria
Revision shoulder arthroplasty.
Reverse shoulder arthroplasty for fracture.
Need for structural glenoid bone graft.
Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a
secondary remote infection is suspected or confirmed, implementation should be
delayed until infection is resolved.
Inadequate or malformed bone that precludes adequate support or fixation of the
prosthesis.
Neuromuscular disorders that do not allow control of the joint.
Significant injury to the brachial plexus.
Non-functional deltoid muscles.
The patient is unwilling or unable to comply with the post-operative care
instructions.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81649.058.22 |