The purpose of this study is to evaluate whether the Anchor Peg Glenoid provides adequate stability in the first en second year after surgery. Therefore, the migration pattern is determined after 3, 6. 12 and 24 months. The correlation with…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is stability as measured with Radio Stereometric
Analysis (RSA)
Secondary outcome
The secondary study parameters are:
radiographic evaluation
radiolucency, scored through a modification for pegged components of the
Franklin system, grading radiolucent lines bordering keeled components grade of
glenoid component seating
pain, scored through 10-cm Visual Analog Scale (VAS)
functional outcome, scored through Constant-Murley Score, Nederlandse Schouder
Test, DASHscore
Background summary
A painful shoulder is a symptom of diseases such as osteoarthritis and
rheumatoid arthritis. These conditions are characterized by degeneration of
articular cartilage and subchondral bone with diminished glenohumeral joint
space. It can significantly decrease the functional capacity of these patients
and even lead to the patient*s becoming fully dependent on others.
The goals of treatment include reduction of pain and improvement of function.
Optional treatments for these patients are conservative treatment (analgesics)
and Shoulder Arthroplasty. With regard to shoulder arthroplasty, the most
important goals are the stability of the joint, pain free movement, and
sufficient range of motion (ROM) for activities of daily living (ADL). The
primary benefit from such surgery is pain reduction. The principle disadvantage
of treatment with a total shoulder arthroplasty is the possible loosening due
to wear particles or contact stresses on the glenoid component.
Radiolucent lines on plain radiographs are not reliable for early loosing. When
traditional radiographs are used for assessment, the rate of early loosening is
underestimated. Radiostereometric analysis (RSA) is recommended to be used for
this. [1,2,3]
The Anchor Peg Glenoid (DePuy International Ltd.) is an all-polyethylene,
minimally cemented, pegged glenoid prosthesis. It features a circumferentially
fluted, central, interference fit peg for tissue integration and three small,
cemented, peripheral pegs. This glenoid is designed to improve fixation,
compared to conventional all-polyethylene keeled and pegged glenoids.
Study objective
The purpose of this study is to evaluate whether the Anchor Peg Glenoid
provides adequate stability in the first en second year after surgery.
Therefore, the migration pattern is determined after 3, 6. 12 and 24 months.
The correlation with radiolucency iwill be evaluated, scored on regular X-rays.
Clinical functioning is registered.
This study intends to answer the following questions:
What is the migration pattern of the Anchor Peg Glenoid ?
Is the design sufficient to guarantee stability and good clinical performance ?
Study design
Prospective, observational (cohort) RSA study
Study burden and risks
Patients visit the clinic 6 times in 2 years. The intervantion is th usual
(standard) procedure with foloow ups and measures. The only difference is the
RSA. The RSA is used to follow the process of migration and states the risc for
early loosening.
Hengstdal 3
6522 JV Nijmegen
NL
Hengstdal 3
6522 JV Nijmegen
NL
Listed location countries
Age
Inclusion criteria
· Patient presents with shoulder osteoarthritis and requires a TSP.
· Patient reports moderate to severe pain in affected shoulder.
· Patient is 18 to 80 years of age.
· Patient is in stable health and is free of or treated and stabilized for
cardiac, pulmonary, hematological, or other conditions that would pose
excessive operative risk.
Exclusion criteria
· Patient diagnosed with posttraumatic osteoarthritis of the shoulder.
· Patient has an active, local infection or systemic infection.
· Patient has a BMI >35.
· Patient has physical, emotional or neurological conditions that would
compromise the patient*s compliance with postoperative rehabilitation
protocol follow-up (e.g.: drug or alcohol abuse, serious mental illness, or
general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
· Patient is pregnant or plans to become pregnant during the course of the RSA
study.
· Patient suffering postoperative complications such as infections,
recurrent luxations, non compliance with normal postoperative care /
rehabilitation program.
Design
Recruitment
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 | NL21091.072.09 |