Evaluation of PR Fixation in Tile B2 and C1 InjuriesPhase 2APRNCT05042297
Combined Ring (APR) Fixation Vs Posterior Ring Fixation in Tile B2 and C1 Pelvic Ring Injuries
A Phase 2 study testing Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention in people with Evaluation of PR Fixation in Tile B2 and C1 Injuries, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim for surgical treatment of unstable Tile B2 \& C1 pelvic ring injuries is an anatomical reduction to allow early weight-bearing, pain relief and to prevent future pelvic asymmetry. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Evaluation of PR Fixation in Tile B2 and C1 Injuries
- What is being tested?
- Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Mar 2019to 15 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Tile B2 and C1 pelvic ring injuries
- Nakatani zone II pubic rami fractures with intact inguinal ligament
- Age between 16-60 years old
- recent pelvic ring injuries less than three weeks
Who cannot join
- Tile A pelvic ring injuries
- Nakatani zone I \& III pubic rami fractures
- neglected pelvic ring injuries exceeding three weeks
- Age less than 16 years and older than 60 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Posterior and Anterior Ring Fixation Versus Posterior Ring Fixation Alone in Management of Unstable Tile B2 and C1 Pelvic Ring Injuries: A Randomized Controlled Trial
The aim for surgical treatment of unstable Tile B2 \& C1 pelvic ring injuries is an anatomical reduction to allow early weight-bearing, pain relief and to prevent future pelvic asymmetry. So, we usually used combined posterior \& anterior ring fixation, relying on the fact that anterior pelvic ring adequate reduction and fixation better augment posterior ring fixation and enhance overall pelvic stability. However, anterior ring fixation requires a second incision with a longer operation time and more blood loss. The main disadvantage of the second incision is the higher risk of wound infection, either superficial or deep, which questions its necessity and raises concerns about the possibility of isolated posterior ring fixation in managing Tile B2 \& C1 pelvic ring injuries with good outcomes.
The fundamental algorithm was the questionable need for additional anterior ring fixation in managing Tile B2 and C1 pelvic ring injuries combined with posterior ring fixation, whether the incidence of postoperative complications, radiological and clinical outcomes differed between these two groups. After reviewing the literature, we found a lack of knowledge in the prospective assessment of such outcomes between the two fixation groups. So, This RCT aims to reach a satisfactory result and prove or deny the questionable need for anterior ring fixation in managing Tile B2 and C1 pelvic ring injuries. Our hypothesis was that PR fixation is at least as good as APR fixation.
Read the detailed description
Type of Study: Prospective randomized controlled clinical trial Randomization technique: Block Randomization. Study Setting: The operations were held in Ain Shams university hospitals. Study Period: From 2019 till 2020.
Study Population:
Inclusion Criteria:
Tile B2 and C1 pelvic ring injuries Nakatani zone II pubic rami fractures with intact inguinal ligament Age between 16-60 years old Recent pelvic ring injuries less than three weeks
Exclusion Criteria:
Tile A pelvic ring injuries Nakatani zone I \& III pubic rami fractures neglected pelvic ring injuries exceeding three weeks Age less than 16 years and older than 60 years
Sampling Method: convenient sample. Sample Size: 40 feet subdivided randomly via Block Randomization into 2 groups, 20 feet for each group.
Group A: Patients treated by combined posterior and anterior ring fixation Group B: Patients treated by posterior ring fixation alone
Ethical Considerations: were followed by obtaining the hospital Research Ethics Committee approval and written informed consents from the patients.
Study Tools:
The patients were evaluated by the following: -
All patients were subjected to:
- Pre-operative:
Written consent.
Complete ATLS protocol:
Primary survey: airway, breathing, circulation and disability with complete exposure, including: CXR and pelvis anteroposterior view Secondary survey: head to toe examination, complete cervical clinical and radiological clearance and detailed AMPLE history
Detailed history:
History-taking included age, mode of trauma, physiological status, haemodynamics, associated internal organ injuries, medical comorbidities and detailed surgical history.
Complete Orthopaedic examination:
Full and thorough examination of the patient was done from head to toes with complete inspection, palpation and range of motion examination of the whole body, together with detailed neurovascular examination of both lower limbs.
X-Rays pre and post-operative Preoperative: to assess the fracture pattern, location and for surgical planning.
Postoperatively: to assess the quality of reduction immediate postoperative and at each follow up visit (two weeks, six weeks, three months, six months and one year) to follow up union rate, fixation failure, secondary dislocation and secondary loss of reduction.
CT pelvis preoperative will be done to accurately describe fracture pattern, identify occult radiological instability and more comprehensive surgical planning.
Evaluation of the patients by clinical Majeed pelvic scoring system
II.Operative technique Group A: combined posterior and anterior ring fixation Group B: Isolated Posterior ring fixation
III. Postoperative management and evaluation:
We followed a partially assisted weight-bearing protocol for six weeks for both groups (using axillary or forearm crutches that take about 50% of the body weight through the injured lower extremity). In addition, we did x-ray films \& neurovascular examination postoperatively.
Follow-up visits were at two weeks, six weeks, three months, six months \& 1-year postoperative.
We performed radiological and clinical assessments: Radiological using Matta \& Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views \& CT pelvis if available; we evaluated five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation, and gapping of the sacroiliac joint; according to the grading of Matta and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm). In addition, clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented, Postoperative complications and need for another operation were evaluated.
In week two, we encouraged passive and active-assisted hip ROM. Then we started an unassisted weight-bearing and physiotherapy program to strengthen abductors and quadriceps muscles in week six. While complete full weight-bearing and return to work were after three months. After six months, a full radiological and clinical assessment were done + return to pre-injury mobility status and athletic sports. Finally, after one year, we did clinical and radiological reevaluation.
IV- Statistical analysis of data.
V- Outcome measures of interest:
Primary outcomes: radiological (using Matta \& Tornetta radiological principles) \& clinical outcomes (using the Majeed pelvic scoring system), and postoperative complications.
Secondary outcomes: operative time, amount of blood loss, intraoperative assessment of reduction, need for another operation, length of hospital stay, ability to weight bear postoperative, and pain control metrics.
- Being tested
- Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention
- Keywords
- Tile B2 and C1 pelvic ring injuries, Posterior ring fixation, Sacroiliac Screw, Radiological outcome, Majeed Pelvic Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental interventionProcedure or surgery
Reduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach. Anterior pelvic ring reduction and fixation in the combined APR fixation group was done via the classic Pfannenstiel approach or extension more lateral \& completing the anterior intrapelvic approach. Fixation was via pubic rami plating.
| Study group | Role | What they receive |
|---|---|---|
| Combined Posterior and anterior ring fixation | Active comparator | Posterior ring fixation via a single posterior Sacroiliac screw or two Iliac wing plates. While anterior ring fixation was via a single para-symphyseal plate in Tile B2 injuries. Meanwhile, we used double superior and anterior symphyseal plates in Tile C1 injuries. Receives: Procedure: Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention |
| Isolated Posterior ring fixation | Experimental | We used either two Sacroiliac screws in S1 and S2, or two Iliac wing plates. Receives: Procedure: Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Excellent, Good, Fair, or Poor Radiological Outcomes
Radiological assessment using Matta \& Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views \& CT pelvis if available; we evaluated five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation, and gapping of the sacroiliac joint; according to the grading of Matta and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm).
Measured: one year postoperative
Rate of Excellent, Good, or Fair Clinical Outcomes
clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented
Measured: one year postoperative
Postoperative Complications' Rate
We focused the evaluation of Postoperative complications on the local complications related to fixation principles and technique rather than general complications related to the patient status and associated injuries: LLD, foot drop, SI screw cut out, wound infection, residual malunion or non-union of the anterior or posterior ring, and loss of reduction (2ry SI dislocation or any rotational or vertical re-displacement that exceeds 2 cm or posterior sacral fracture gap that exceeds 1 cm)
Measured: Through study completion, an average of 1 year postoperative
Secondary outcomes (7)
Mean Operative Time
The mean operation time was calculated and compared between the two study groups
Measured: It was calculated intra-operative
Mean Intraoperative Blood Loss
The mean blood loss was calculated and compared between the two study groups, it was measured intraoperative and postoperative from suction drains
Measured: Up to 4 days postoperative
Need For Another Operations' Rate
The need for another operation was observed and compared between the two study groups
Measured: Through study completion, an average of 1 year postoperative
Rate of Anatomical, Acceptable, or Non-anatomic Intraoperative Assessment of Reduction
The intraoperative assessment of reduction was performed and compared the results between the two study groups
Measured: It was performed intraoperative
The Average Length OF Hospital Stay
The average hospital stay postoperative was calculated and compared between the two study groups
Measured: Up to 4 days postoperative
Number of participants Able To Weight-bear Postoperative
We observed the ability of the patients to toe-touch weight-bear immediate postoperative, and it was compared between the two study groups
Measured: Up to one year postoperative
Number of participants that required IV Opiods as an Analgesia
The analgesica requirements between the two study groups were analyzed and compared, it ranged from users of paracetamol to those who needed IV opiods
Measured: up to 4 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start9 Mar 2019
- Primary completion7 Jul 2020
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Evaluation of PR Fixation in Tile B2 and C1 InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. We prospectively carried out this study on 40 patients with Tile B2 \& C1 injuries between March 2019 and July 2020 that met our inclusion criteria. The independent doctor allocated the 40 cases to two groups: Group A (20 cases): combined posterior and anterior ring fixation (APR fixation group), group B (20 cases): isolated posterior ring fixation (PR fixation group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Moussa, Ain Shams University
- Investigators
- Amr K. Mahmoud, Professor, Principal investigator, no funding recieved
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042297
- Sponsor's protocol ID
- FMASU MD 272/2019
- Acronym
- APR
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmal H, Froberg L, S Larsen M, Sudkamp NP, Pohlemann T, Aghayev E, Goodwin Burri K. Evaluation of strategies for the treatment of type B and C pelvic fractures: results from the German Pelvic Injury Register. Bone Joint J. 2018 Jul;100-B(7):973-983. doi: 10.1302/0301-620X.100B7.BJJ-2017-1377.R1.
PubMed 29954203Pohlemann T, Stengel D, Tosounidis G, Reilmann H, Stuby F, Stockle U, Seekamp A, Schmal H, Thannheimer A, Holmenschlager F, Gansslen A, Rommens PM, Fuchs T, Baumgartel F, Marintschev I, Krischak G, Wunder S, Tscherne H, Culemann U. Survival trends and predictors of mortality in severe pelvic trauma: estimates from the German Pelvic Trauma Registry Initiative. Injury. 2011 Oct;42(10):997-1002. doi: 10.1016/j.injury.2011.03.053. Epub 2011 Apr 22.
PubMed 21513936Hauschild O, Strohm PC, Culemann U, Pohlemann T, Suedkamp NP, Koestler W, Schmal H. Mortality in patients with pelvic fractures: results from the German pelvic injury register. J Trauma. 2008 Feb;64(2):449-55. doi: 10.1097/TA.0b013e31815982b1.
PubMed 18301214Osterhoff G, Ossendorf C, Wanner GA, Simmen HP, Werner CM. Percutaneous iliosacral screw fixation in S1 and S2 for posterior pelvic ring injuries: technique and perioperative complications. Arch Orthop Trauma Surg. 2011 Jun;131(6):809-13. doi: 10.1007/s00402-010-1230-0. Epub 2010 Dec 28.
PubMed 21188399Sagi HC, Coniglione FM, Stanford JH. Examination under anesthetic for occult pelvic ring instability. J Orthop Trauma. 2011 Sep;25(9):529-36. doi: 10.1097/BOT.0b013e31822b02ae.
PubMed 21857421
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Posterior and Anterior Ring Fixation Versus Posterior Ring Fixation Alone in Management of Unstable Tile B2 and C1 Pelvic Ring Injuries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05042297
- Acronym / sponsor ID
- APR / FMASU MD 272/2019
- Keywords
- Tile B2 and C1 pelvic ring injuries, Posterior ring fixation, Sacroiliac Screw, Radiological outcome, Majeed Pelvic Score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim for surgical treatment of unstable Tile B2 \& C1 pelvic ring injuries is an anatomical reduction to allow early weight-bearing, pain relief and to prevent future pelvic asymmetry. So, we usually used combined posterior \& anterior ring fixation, relying on the fact that anterior pelvic ring adequate reduction and fixation better augment posterior ring fixation and enhance overall pelvic stability. However, anterior ring fixation requires a second incision with a longer operation time and more blood loss. The main disadvantage of the second incision is the higher risk of wound infection, either superficial or deep, which questions its necessity and raises concerns about the possibility of isolated posterior ring fixation in managing Tile B2 \& C1 pelvic ring injuries with good outcomes.
The fundamental algorithm was the questionable need for additional anterior ring fixation in managing Tile B2 and C1 pelvic ring injuries combined with posterior ring fixation, whether the incidence of postoperative complications, radiological and clinical outcomes differed between these two groups. After reviewing the literature, we found a lack of knowledge in the prospective assessment of such outcomes between the two fixation groups. So, This RCT aims to reach a satisfactory result and prove or deny the questionable need for anterior ring fixation in managing Tile B2 and C1 pelvic ring injuries. Our hypothesis was that PR fixation is at least as good as APR fixation.
Detailed description
Type of Study: Prospective randomized controlled clinical trial Randomization technique: Block Randomization. Study Setting: The operations were held in Ain Shams university hospitals. Study Period: From 2019 till 2020.
Study Population:
Inclusion Criteria:
Tile B2 and C1 pelvic ring injuries Nakatani zone II pubic rami fractures with intact inguinal ligament Age between 16-60 years old Recent pelvic ring injuries less than three weeks
Exclusion Criteria:
Tile A pelvic ring injuries Nakatani zone I \& III pubic rami fractures neglected pelvic ring injuries exceeding three weeks Age less than 16 years and older than 60 years
Sampling Method: convenient sample. Sample Size: 40 feet subdivided randomly via Block Randomization into 2 groups, 20 feet for each group.
Group A: Patients treated by combined posterior and anterior ring fixation Group B: Patients treated by posterior ring fixation alone
Ethical Considerations: were followed by obtaining the hospital Research Ethics Committee approval and written informed consents from the patients.
Study Tools:
The patients were evaluated by the following: -
All patients were subjected to:
- Pre-operative:
Written consent.
Complete ATLS protocol:
Primary survey: airway, breathing, circulation and disability with complete exposure, including: CXR and pelvis anteroposterior view Secondary survey: head to toe examination, complete cervical clinical and radiological clearance and detailed AMPLE history
Detailed history:
History-taking included age, mode of trauma, physiological status, haemodynamics, associated internal organ injuries, medical comorbidities and detailed surgical history.
Complete Orthopaedic examination:
Full and thorough examination of the patient was done from head to toes with complete inspection, palpation and range of motion examination of the whole body, together with detailed neurovascular examination of both lower limbs.
X-Rays pre and post-operative Preoperative: to assess the fracture pattern, location and for surgical planning.
Postoperatively: to assess the quality of reduction immediate postoperative and at each follow up visit (two weeks, six weeks, three months, six months and one year) to follow up union rate, fixation failure, secondary dislocation and secondary loss of reduction.
CT pelvis preoperative will be done to accurately describe fracture pattern, identify occult radiological instability and more comprehensive surgical planning.
Evaluation of the patients by clinical Majeed pelvic scoring system
II.Operative technique Group A: combined posterior and anterior ring fixation Group B: Isolated Posterior ring fixation
III. Postoperative management and evaluation:
We followed a partially assisted weight-bearing protocol for six weeks for both groups (using axillary or forearm crutches that take about 50% of the body weight through the injured lower extremity). In addition, we did x-ray films \& neurovascular examination postoperatively.
Follow-up visits were at two weeks, six weeks, three months, six months \& 1-year postoperative.
We performed radiological and clinical assessments: Radiological using Matta \& Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views \& CT pelvis if available; we evaluated five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation, and gapping of the sacroiliac joint; according to the grading of Matta and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm). In addition, clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented, Postoperative complications and need for another operation were evaluated.
In week two, we encouraged passive and active-assisted hip ROM. Then we started an unassisted weight-bearing and physiotherapy program to strengthen abductors and quadriceps muscles in week six. While complete full weight-bearing and return to work were after three months. After six months, a full radiological and clinical assessment were done + return to pre-injury mobility status and athletic sports. Finally, after one year, we did clinical and radiological reevaluation.
IV- Statistical analysis of data.
V- Outcome measures of interest:
Primary outcomes: radiological (using Matta \& Tornetta radiological principles) \& clinical outcomes (using the Majeed pelvic scoring system), and postoperative complications.
Secondary outcomes: operative time, amount of blood loss, intraoperative assessment of reduction, need for another operation, length of hospital stay, ability to weight bear postoperative, and pain control metrics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. We prospectively carried out this study on 40 patients with Tile B2 \& C1 injuries between March 2019 and July 2020 that met our inclusion criteria. The independent doctor allocated the 40 cases to two groups: Group A (20 cases): combined posterior and anterior ring fixation (APR fixation group), group B (20 cases): isolated posterior ring fixation (PR fixation group).
| Arm | Type | Receives |
|---|---|---|
| Combined Posterior and anterior ring fixation | Active comparator | Procedure: Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental interventionPosterior ring fixation via a single posterior Sacroiliac screw or two Iliac wing plates. While anterior ring fixation was via a single para-symphyseal plate in Tile B2 injuries. Meanwhile, we used double superior and anterior symphyseal plates in Tile C1 injuries. |
| Isolated Posterior ring fixation | Experimental | Procedure: Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental interventionWe used either two Sacroiliac screws in S1 and S2, or two Iliac wing plates. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Tile B2 and C1 pelvic ring injuries
- Nakatani zone II pubic rami fractures with intact inguinal ligament
- Age between 16-60 years old
- recent pelvic ring injuries less than three weeks
Key exclusion criteria (4 listed)
- Tile A pelvic ring injuries
- Nakatani zone I \& III pubic rami fractures
- neglected pelvic ring injuries exceeding three weeks
- Age less than 16 years and older than 60 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental interventionReduction of the posterior ring was either closed reduction in SI joint dislocations \& fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach. Anterior pelvic ring reduction and fixation in the combined APR fixation group was done via the classic Pfannenstiel approach or extension more lateral \& completing the anterior intrapelvic approach. Fixation was via pubic rami plating. | Procedure or surgery | Combined Posterior and anterior ring fixation, Isolated Posterior ring fixation |
Primary outcome
Rate of Excellent, Good, Fair, or Poor Radiological Outcomes
Time frame: one year postoperative
Radiological assessment using Matta \& Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views \& CT pelvis if available; we evaluated five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation, and gapping of the sacroiliac joint; according to the grading of Matta and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm).
Rate of Excellent, Good, or Fair Clinical Outcomes
Time frame: one year postoperative
clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented
Postoperative Complications' Rate
Time frame: Through study completion, an average of 1 year postoperative
We focused the evaluation of Postoperative complications on the local complications related to fixation principles and technique rather than general complications related to the patient status and associated injuries: LLD, foot drop, SI screw cut out, wound infection, residual malunion or non-union of the anterior or posterior ring, and loss of reduction (2ry SI dislocation or any rotational or vertical re-displacement that exceeds 2 cm or posterior sacral fracture gap that exceeds 1 cm)
7 secondary outcomes
Mean Operative Time
Time frame: It was calculated intra-operative
Mean Intraoperative Blood Loss
Time frame: Up to 4 days postoperative
Need For Another Operations' Rate
Time frame: Through study completion, an average of 1 year postoperative
Rate of Anatomical, Acceptable, or Non-anatomic Intraoperative Assessment of Reduction
Time frame: It was performed intraoperative
The Average Length OF Hospital Stay
Time frame: Up to 4 days postoperative
Number of participants Able To Weight-bear Postoperative
Time frame: Up to one year postoperative
Number of participants that required IV Opiods as an Analgesia
Time frame: up to 4 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Background: PubMed 29954203Schmal H, Froberg L, S Larsen M, Sudkamp NP, Pohlemann T, Aghayev E, Goodwin Burri K. Evaluation of strategies for the treatment of type B and C pelvic fractures: results from the German Pelvic Injury Register. Bone Joint J. 2018 Jul;100-B(7):973-983. doi: 10.1302/0301-620X.100B7.BJJ-2017-1377.R1.
- Results publication: PubMed 21513936Pohlemann T, Stengel D, Tosounidis G, Reilmann H, Stuby F, Stockle U, Seekamp A, Schmal H, Thannheimer A, Holmenschlager F, Gansslen A, Rommens PM, Fuchs T, Baumgartel F, Marintschev I, Krischak G, Wunder S, Tscherne H, Culemann U. Survival trends and predictors of mortality in severe pelvic trauma: estimates from the German Pelvic Trauma Registry Initiative. Injury. 2011 Oct;42(10):997-1002. doi: 10.1016/j.injury.2011.03.053. Epub 2011 Apr 22.
- Results publication: PubMed 18301214Hauschild O, Strohm PC, Culemann U, Pohlemann T, Suedkamp NP, Koestler W, Schmal H. Mortality in patients with pelvic fractures: results from the German pelvic injury register. J Trauma. 2008 Feb;64(2):449-55. doi: 10.1097/TA.0b013e31815982b1.
- Results publication: PubMed 21188399Osterhoff G, Ossendorf C, Wanner GA, Simmen HP, Werner CM. Percutaneous iliosacral screw fixation in S1 and S2 for posterior pelvic ring injuries: technique and perioperative complications. Arch Orthop Trauma Surg. 2011 Jun;131(6):809-13. doi: 10.1007/s00402-010-1230-0. Epub 2010 Dec 28.
- Results publication: PubMed 21857421Sagi HC, Coniglione FM, Stanford JH. Examination under anesthetic for occult pelvic ring instability. J Orthop Trauma. 2011 Sep;25(9):529-36. doi: 10.1097/BOT.0b013e31822b02ae.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr K. Mahmoud, Professor principal investigator
no funding recieved
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention in people with Evaluation of PR Fixation in Tile B2 and C1 Injuries, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Excellent, Good, Fair, or Poor Radiological Outcomes (time frame: one year postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05042297, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.