Trial Outcomes & Findings for PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System (NCT NCT05215626)
NCT ID: NCT05215626
Last Updated: 2026-03-10
Results Overview
Performance will be assessed by analyzing fracture healing radiographically by X-rays.
Recruitment status
COMPLETED
Target enrollment
78 participants
Primary outcome timeframe
Mean time of 1.99 years after the surgery
Results posted on
2026-03-10
Participant Flow
Azienda Ospedaliero Universitaria Senese, Siena, Italy
78 consecutive patients (84 cases) were identified at the Azienda Ospedaliero Universitaria Senese and were enrolled in this study
Unit of analysis: Cases
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
78 84
|
|
Overall Study
COMPLETED
|
78 84
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System
Baseline characteristics by cohort
| Measure |
Patients Implanted With the Zimmer Reconstruction System
n=84 Cases
Patients who received the Zimmer Reconstruction System when used for temporary internal fixation and stabilization of fractures during the normal healing process.
|
|---|---|
|
Anatomical location
62A1.1: simple fracture
|
2 Cases
n=84 Cases
|
|
Age, Continuous
|
46.89 years
STANDARD_DEVIATION 16.21 • n=84 Cases
|
|
Sex: Female, Male
Female
|
16 Cases
n=84 Cases
|
|
Sex: Female, Male
Male
|
68 Cases
n=84 Cases
|
|
Weight
|
78.79 kg
STANDARD_DEVIATION 13.65 • n=84 Cases
|
|
Height
|
173.88 cm
STANDARD_DEVIATION 6.66 • n=84 Cases
|
|
BMI
|
25.92 kg/m^2
STANDARD_DEVIATION 3.32 • n=84 Cases
|
|
Confounders for bone union
None
|
26 Cases
n=84 Cases
|
|
Confounders for bone union
Frailty
|
7 Cases
n=84 Cases
|
|
Confounders for bone union
Smoking
|
2 Cases
n=84 Cases
|
|
Confounders for bone union
High energy accident
|
45 Cases
n=84 Cases
|
|
Confounders for bone union
Comminution of bone
|
2 Cases
n=84 Cases
|
|
Confounders for bone union
Others
|
2 Cases
n=84 Cases
|
|
Concomitant diseases
None
|
79 Cases
n=84 Cases
|
|
Concomitant diseases
Osteoporosis
|
1 Cases
n=84 Cases
|
|
Concomitant diseases
Others
|
4 Cases
n=84 Cases
|
|
Fracture Cause
Motor vehicle accident
|
49 Cases
n=84 Cases
|
|
Fracture Cause
Sport accident
|
15 Cases
n=84 Cases
|
|
Fracture Cause
Fall from height
|
8 Cases
n=84 Cases
|
|
Fracture Cause
Others
|
12 Cases
n=84 Cases
|
|
Anatomical location
62A1: posterior wall fracture with or without marginal impaction
|
9 Cases
n=84 Cases
|
|
Anatomical location
62A1.2: multifragmentary fracture
|
5 Cases
n=84 Cases
|
|
Anatomical location
62A2: posterior column fracture
|
8 Cases
n=84 Cases
|
|
Anatomical location
62A2.1: with ischial bone involvement
|
6 Cases
n=84 Cases
|
|
Anatomical location
62A2.2: with obturator ring involvement
|
2 Cases
n=84 Cases
|
|
Anatomical location
62A2.3: with simple or multifragmentary posterior wall fracture and possible marginal impaction
|
2 Cases
n=84 Cases
|
|
Anatomical location
62A3: anterior wall or column fracture with or without marginal impaction
|
1 Cases
n=84 Cases
|
|
Anatomical location
62A3.2: high anterior column fracture through the iliac crest
|
9 Cases
n=84 Cases
|
|
Anatomical location
62A3.3: low anterior column fracture below the anterior superior iliac spine
|
5 Cases
n=84 Cases
|
|
Anatomical location
62B1: transverse fracture ± posterior wall fracture ± marginal impaction
|
7 Cases
n=84 Cases
|
|
Anatomical location
62B2: T-fracture ± posterior wall fracture ± marginal impaction
|
1 Cases
n=84 Cases
|
|
Anatomical location
62B3: posterior hemitransverse and anterior wall or column fracture
|
1 Cases
n=84 Cases
|
|
Anatomical location
B1: open-book injury (external rotation)
|
14 Cases
n=84 Cases
|
|
Anatomical location
B2: lateral-compression injury (internal rotation)
|
2 Cases
n=84 Cases
|
|
Anatomical location
B2-1: ipsilateral anterior and posterior injuries
|
8 Cases
n=84 Cases
|
|
Anatomical location
B2-2: contralateral (bucket-handle) injuries
|
2 Cases
n=84 Cases
|
|
Open or Closed Fracture
Open
|
1 Cases
n=84 Cases
|
|
Open or Closed Fracture
Closed
|
83 Cases
n=84 Cases
|
|
Existence of additional fractures at the time of hospital admission
Yes
|
76 Cases
n=84 Cases
|
|
Existence of additional fractures at the time of hospital admission
No
|
8 Cases
n=84 Cases
|
|
Operation Time (skin-to-skin)
|
143.21 minutes
STANDARD_DEVIATION 45.75 • n=84 Cases
|
|
Operated Side
Left
|
39 Cases
n=84 Cases
|
|
Operated Side
Right
|
26 Cases
n=84 Cases
|
|
Operated Side
N/A
|
19 Cases
n=84 Cases
|
|
Surgical Approach
Kocher-Langenbeck
|
40 Cases
n=84 Cases
|
|
Surgical Approach
Anterior
|
40 Cases
n=84 Cases
|
|
Surgical Approach
Ileoinguinal
|
4 Cases
n=84 Cases
|
|
Length of Hospital Stay
|
10.83 days
STANDARD_DEVIATION 6.84 • n=84 Cases
|
PRIMARY outcome
Timeframe: Mean time of 1.99 years after the surgeryPerformance will be assessed by analyzing fracture healing radiographically by X-rays.
Outcome measures
| Measure |
Patients Implanted With the Zimmer Reconstruction System
n=84 Cases
Patients who received the Zimmer Reconstruction System when used for temporary internal fixation and stabilization of fractures during the normal healing process.
|
|---|---|
|
Performance: Fracture Healing
Union (radiographic evaluation)
|
84 Cases
|
|
Performance: Fracture Healing
Non-union (radiographic evaluation)
|
0 Cases
|
SECONDARY outcome
Timeframe: Mean time of 1.99 years after the surgeryPopulation: Further information on complications and adverse events is unknown and cannot be collected.
Safety will be assessed by recording and analyzing the incidence and frequency of complications during the study
Outcome measures
| Measure |
Patients Implanted With the Zimmer Reconstruction System
n=84 Cases
Patients who received the Zimmer Reconstruction System when used for temporary internal fixation and stabilization of fractures during the normal healing process.
|
|---|---|
|
Product Safety
No complication
|
68 Cases
|
|
Product Safety
Complication
|
16 Cases
|
SECONDARY outcome
Timeframe: Mean time of 1.99 years after the surgeryClinical 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).
Outcome measures
| Measure |
Patients Implanted With the Zimmer Reconstruction System
n=84 Cases
Patients who received the Zimmer Reconstruction System when used for temporary internal fixation and stabilization of fractures during the normal healing process.
|
|---|---|
|
Harris Hip Score
Excellent (=100-90)
|
59 Cases
|
|
Harris Hip Score
Good (=89-80)
|
17 Cases
|
|
Harris Hip Score
Fair (=79-70)
|
7 Cases
|
|
Harris Hip Score
Poor (= <70)
|
1 Cases
|
Adverse Events
Patients Implanted With the Zimmer Reconstruction System
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients Implanted With the Zimmer Reconstruction System
n=78 participants at risk
Patients who received the Zimmer Reconstruction System when used for temporary internal fixation and stabilization of fractures during the normal healing process.
|
|---|---|
|
General disorders
Overall complication rate
|
20.5%
16/78 • Number of events 16 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60