Acetabulum Fracture, Pelvic Ring Fracture
Conditions
Keywords
Acetabulum Fracture, Pelvic Ring Fracture, Medical Device, Clinical Benefits, Safety, Performance, Post Market Clinical Follow Up Study
Brief summary
The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Reconstruction System (implants and instrumentation) when used for temporary internal fixation and stabilization of fractures during the normal healing process. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.
Detailed description
The Reconstruction System is especially used to stabilize pelvic ring and acetabulum fractures. One site will be involved in this study. The aim is to include a maximum of 83 consecutive series cases who received the Zimmer Reconstruction System at the Azienda Ospedaliero Universitaria Senese (Siena, Italy) between 2010 and 2018. All potential study subjects will be required to participate to the Informed Consent process. Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected retrospectively.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients having received the Zimmer Reconstruction System for temporary internal fixation and stabilization of fractures during the normal healing process
Exclusion criteria
* Off-label use * Patients under the age of 18 * Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position * Infection * Metal sensitivity or intolerance * Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation * Sternal or spinal fractures * Anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures * Patients with inadequate soft tissue coverage at the implant site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance: Fracture Healing | Mean time of 1.99 years after the surgery | Performance will be assessed by analyzing fracture healing radiographically by X-rays. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Product Safety | Mean time of 1.99 years after the surgery | Safety will be assessed by recording and analyzing the incidence and frequency of complications during the study |
| Harris Hip Score | Mean time of 1.99 years after the surgery | Clinical benefits will be assessed by evaluating the Harris Hip Score (HHS). The HHS consists of four subscales (pain, function, the absence of deformity and range of motion). The survey has 10 question items and the score will range from 0 (worst) to 100 (best). |
Countries
Italy
Contacts
STUDY_DIRECTOREmilie Rohmer
Zimmer Biomet
Participant flow
Recruitment details
Azienda Ospedaliero Universitaria Senese, Siena, Italy
Pre-assignment details
78 consecutive patients (84 cases) were identified at the Azienda Ospedaliero Universitaria Senese and were enrolled in this study
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46.89 years STANDARD_DEVIATION 16.21 |
| Anatomical location 62A1.1: simple fracture | 2 Cases |
| Anatomical location 62A1.2: multifragmentary fracture | 5 Cases |
| Anatomical location 62A1: posterior wall fracture with or without marginal impaction | 9 Cases |
| Anatomical location 62A2.1: with ischial bone involvement | 6 Cases |
| Anatomical location 62A2.2: with obturator ring involvement | 2 Cases |
| Anatomical location 62A2.3: with simple or multifragmentary posterior wall fracture and possible marginal impaction | 2 Cases |
| Anatomical location 62A2: posterior column fracture | 8 Cases |
| Anatomical location 62A3.2: high anterior column fracture through the iliac crest | 9 Cases |
| Anatomical location 62A3.3: low anterior column fracture below the anterior superior iliac spine | 5 Cases |
| Anatomical location 62A3: anterior wall or column fracture with or without marginal impaction | 1 Cases |
| Anatomical location 62B1: transverse fracture ± posterior wall fracture ± marginal impaction | 7 Cases |
| Anatomical location 62B2: T-fracture ± posterior wall fracture ± marginal impaction | 1 Cases |
| Anatomical location 62B3: posterior hemitransverse and anterior wall or column fracture | 1 Cases |
| Anatomical location B1: open-book injury (external rotation) | 14 Cases |
| Anatomical location B2-1: ipsilateral anterior and posterior injuries | 8 Cases |
| Anatomical location B2-2: contralateral (bucket-handle) injuries | 2 Cases |
| Anatomical location B2: lateral-compression injury (internal rotation) | 2 Cases |
| BMI | 25.92 kg/m^2 STANDARD_DEVIATION 3.32 |
| Concomitant diseases None | 79 Cases |
| Concomitant diseases Osteoporosis | 1 Cases |
| Concomitant diseases Others | 4 Cases |
| Confounders for bone union Comminution of bone | 2 Cases |
| Confounders for bone union Frailty | 7 Cases |
| Confounders for bone union High energy accident | 45 Cases |
| Confounders for bone union None | 26 Cases |
| Confounders for bone union Others | 2 Cases |
| Confounders for bone union Smoking | 2 Cases |
| Existence of additional fractures at the time of hospital admission No | 8 Cases |
| Existence of additional fractures at the time of hospital admission Yes | 76 Cases |
| Fracture Cause Fall from height | 8 Cases |
| Fracture Cause Motor vehicle accident | 49 Cases |
| Fracture Cause Others | 12 Cases |
| Fracture Cause Sport accident | 15 Cases |
| Height | 173.88 cm STANDARD_DEVIATION 6.66 |
| Length of Hospital Stay | 10.83 days STANDARD_DEVIATION 6.84 |
| Open or Closed Fracture Closed | 83 Cases |
| Open or Closed Fracture Open | 1 Cases |
| Operated Side Left | 39 Cases |
| Operated Side N/A | 19 Cases |
| Operated Side Right | 26 Cases |
| Operation Time (skin-to-skin) | 143.21 minutes STANDARD_DEVIATION 45.75 |
| Sex: Female, Male Female | 16 Cases |
| Sex: Female, Male Male | 68 Cases |
| Surgical Approach Anterior | 40 Cases |
| Surgical Approach Ileoinguinal | 4 Cases |
| Surgical Approach Kocher-Langenbeck | 40 Cases |
| Weight | 78.79 kg STANDARD_DEVIATION 13.65 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 78 |
| other Total, other adverse events | 16 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
None listed