Primary Objective: to determine the status of screw degradation, osseous replacement and host response of a biodegradable self-reinforcedTM poly 96L/4D lactide copolymer and βTCP biocomposite interference screw at five years after an ACL…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters / outcome of the study
• Standardized CT scan at a minimum of five years post-operative.
• Absorption using Housfield unit density (HU)
• Osteoconduction using Barber & Dockery Ossification Quality Score
• Biocompatibility
Secondary outcome
Secondary study parameters / outcome of the study (if applicable)
1. Clinical exam tests and measures (i.e. ROM, Lachmans, Drawer, pivot shift
test, etc.)
2. Functional tests (1 leg hop; jump; squat; etc.)
3. Patient satisfaction outcomes:
• Disease-specific: ACL-QOL
• Joint specific: IKDC
• General Health: SF-36
• Activy Score: Tegner
4. Intra-operative:
• Procedureal details (tunnel length, diameter, etc.)
• Adverse events
Background summary
The new generation of anterior cruciate liament (ACL) reconstruction
interference screws combine bioabsorbable polymers with a ceramic component,
such as beta tricalcium phosphate (bTCP), to create a biocomposite material.
The bioabsorbable polymer degrades overtime providing structural support while
the ceramic component promotes bony ingrowth. The process by which these
polymers degrade is very complex and can result in considerable complication.
There are a multitude of bioabsorbable polymers used in surgery, each with
their own degradation profile. In order for surgeons to make evidence-based
decisions, clinical data on a screws* long-term degradation profile and
associated complications are needed. There is also a paucity of data on the in
vivo osteoconductive properties of biocomposite screws. Pilot studies in human
populations are needed to increase our understanding of these variables before
large scale clinical trials can be conducted. The purpose of this research is
to obtain preliminary data on the long-term bioabsorable and biocomposite
properties of poly 96L/4D lactide copolymer and β-tricalcium phosphate (βTCP)
interference screws in a human population.
Study objective
Primary Objective: to determine the status of screw degradation, osseous
replacement and host response of a biodegradable self-reinforcedTM poly 96L/4D
lactide copolymer and βTCP biocomposite interference screw at five years after
an ACL reconstruction
Secondary Objectives:
1. to explore differences between femoral and tibial sites.
2. to obtain estimates of patient-reported outcomes as measured by disease
specific, joint specific and general health questionnaires (ACL-QOL, IKDC and
SF-36, respectively).
3. to report clinical and functional outcomes.
Study design
Pilot study - Retrospective case-series
Study burden and risks
Patients will be required to return to the clinic for a clinical examination,
complete questionnaires and undergo a CT scan. The clinical exam will take
approximately 30 minutes. The CT scan will take approximately 30 miniutes. The
questionnaires will take approximately 15 minutes..
Patients are exposed to ionizing radiation during CT scan. Exposure is low and
attempts will be made to reduce the time of exposure and, if possible, lower
the radiation doses.
Benefits: detailed information will be revealed about the implanted screw and
surrounding bone, patients will have a clinical exam of their knee stability
and function, and the quality of life questionnaires will reveal how patients
are coping 5 years after their surgery.
Rue du Pont des Halles 3-5
Rungis Cedex 94656
FR
Rue du Pont des Halles 3-5
Rungis Cedex 94656
FR
Listed location countries
Age
Inclusion criteria
- graft fixation with a Matryx interference screw
- Age 18-50 years at time of surgery
- Male
- Primary ACL reconstruction with a single bundle ST or STG autograft
- Minimum 5years postoperative
Exclusion criteria
- Subsequent surgery on the affected limb after the index ACL surgery
- Failed ACL reconstruction: defined as meeting at least one of the following:
Lachman*s of 1+ or greater
Positive pivot shift
IKDC C and D
- Any condition that would exclude a patient from undergoing a CT scan
- Concomitant ligament or bone pathology at the time of index procedure or subsequently
- Double bundle/tunnel
- Smoker
- Diabetic
- Auto-immune conditions
- Elite Athletes
- Metastatic bone disease
- Female (note: excluded due to pregnancy possibility)
Design
Recruitment
Medical products/devices used
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 | NL48632.100.14 |