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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients implanted with the Zimmer Reconstruction System | Patients implanted with the Zimmer Reconstruction System |
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| Measure | Description | Time Frame |
|---|---|---|
| Performance: Fracture Healing | Performance will be assessed by analyzing fracture healing radiographically by X-rays. | Mean time of 1.99 years after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Product Safety | Safety will be assessed by recording and analyzing the incidence and frequency of complications during the study | Mean time of 1.99 years after the surgery |
| Harris Hip Score | 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). |
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Inclusion Criteria:
Patients having received the Zimmer Reconstruction System for temporary internal fixation and stabilization of fractures during the normal healing process
Exclusion Criteria:
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Consecutive series of cases implanted with the Zimmer Reconstruction System according to Zimmer Biomet's Instruction for USE (IFU) and who meet the inclusion criteria and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Rohmer | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Senese | Siena | 53100 | Italy |
78 consecutive patients (84 cases) were identified at the Azienda Ospedaliero Universitaria Senese and were enrolled in this study
Azienda Ospedaliero Universitaria Senese, Siena, Italy
| ID | Title | Description |
|---|---|---|
| FG000 | Patients Implanted With the Zimmer Reconstruction System | Single study patient cohort, including 78 participants (84 cases) who meet the inclusion/exclusion criteria and who received the Zimmer Reconstruction System when used for temporary internal fixation and stabilization of fractures during the normal healing process. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
If an enrolled participant received multiple implants, a dataset has been recorded per fracture site (1 fracture = 1 case). Therefore, all data will be presented in the number of cases.
| ID | Title | Description |
|---|---|---|
| BG000 | Patients Implanted With the Zimmer Reconstruction System | Patients who received the Zimmer Reconstruction System when used for temporary internal fixation and stabilization of fractures during the normal healing process. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Performance: Fracture Healing | Performance will be assessed by analyzing fracture healing radiographically by X-rays. | Posted | Count of Units | Cases | Mean time of 1.99 years after the surgery | Cases | Cases |
|
|
mean time of 1.99 years after the surgery
Complications were collected fully anonymized and the Sponsor was not provided with raw data. Date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Implanted With the Zimmer Reconstruction System | Patients who received the Zimmer Reconstruction System when used for temporary internal fixation and stabilization of fractures during the normal healing process. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overall complication rate | General disorders | Systematic Assessment | No further details were given and can be collected. |
A limitation to this study is its retrospective and fully anonymized design. Due to the fully anonymized design, no further information on complications and adverse events can be collected for this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Georgia Tsapara | Zimmer Biomet | (0)79 94 54936 | +41 | georgia.tsapara@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2021 | Mar 6, 2026 | Prot_SAP_000.pdf |
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| Mean time of 1.99 years after the surgery |
| Cases |
|
| years |
| Cases |
|
|
| Sex: Female, Male | Count of Units | Cases | Cases |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg | Cases |
|
|
| Height | Mean | Standard Deviation | cm | Cases |
|
|
| BMI | Mean | Standard Deviation | kg/m^2 | Cases |
|
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| Confounders for bone union | factors that biologically or systemically impair bone healing and can influence clinical assessment | Count of Units | Cases | Cases |
|
|
| Concomitant diseases | Count of Units | Cases | Cases |
|
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| Fracture Cause | Count of Units | Cases | Cases |
|
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| Anatomical location | Count of Units | Cases | Cases |
|
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| Open or Closed Fracture | Count of Units | Cases | Cases |
|
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| Existence of additional fractures at the time of hospital admission | Count of Units | Cases | Cases |
|
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| Operation Time (skin-to-skin) | Mean | Standard Deviation | minutes | Cases |
|
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| Operated Side | Count of Units | Cases | Cases |
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| Surgical Approach | Count of Units | Cases | Cases |
|
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| Length of Hospital Stay | Mean | Standard Deviation | days | Cases |
|
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| Cases |
|
|
| Secondary | Product Safety | Safety will be assessed by recording and analyzing the incidence and frequency of complications during the study | Further information on complications and adverse events is unknown and cannot be collected. | Posted | Count of Units | Cases | Mean time of 1.99 years after the surgery | Cases | Cases |
|
|
|
| Secondary | Harris Hip Score | 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). | Posted | Count of Units | Cases | Mean time of 1.99 years after the surgery | Cases | Cases |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 16 |
| 78 |
|
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| Comminution of bone |
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| Others |
|
| 62A2.1: with ischial bone involvement |
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| 62A2.2: with obturator ring involvement |
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| 62A2.3: with simple or multifragmentary posterior wall fracture and possible marginal impaction |
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| 62A3: anterior wall or column fracture with or without marginal impaction |
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| 62A3.2: high anterior column fracture through the iliac crest |
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| 62A3.3: low anterior column fracture below the anterior superior iliac spine |
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| 62B1: transverse fracture ± posterior wall fracture ± marginal impaction |
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| 62B2: T-fracture ± posterior wall fracture ± marginal impaction |
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| 62B3: posterior hemitransverse and anterior wall or column fracture |
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| B1: open-book injury (external rotation) |
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| B2: lateral-compression injury (internal rotation) |
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| B2-1: ipsilateral anterior and posterior injuries |
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| B2-2: contralateral (bucket-handle) injuries |
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| Poor (= <70) |
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