Fracture, Healed, Fibrous UnionNonunionNCT02951468
Mid-term Outcome Following Revision Surgery of Clavicular Non- and Malunion
An observational study of Fracture, Healed, Fibrous Union, run by Technical University of Munich.
Trial summary
Background Treatment of clavicular non- and malunion is still challenging. Current surgical procedures often result in partially frustrating functional outcome along with high-grade subjective impairment and increased rates of revision surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fracture, Healed, Fibrous Union
- What is being tested?
- LCP plus iliac crest autograft
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Feb 2016
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from clavicular non-unions or malunions
Who may be able to join
- clavicular non-unions or malunions
Who cannot join
- none
About this study
Official title: Mid-term Outcome Following Revision Surgery of Clavicular Non- and Malunion Using Anatomic Locking Compression Plate and Iliac Crest Bone Graft
Background Treatment of clavicular non- and malunion is still challenging. Current surgical procedures often result in partially frustrating functional outcome along with high-grade subjective impairment and increased rates of revision surgery. However, the combination of vital bone graft and a biomechanically sufficient fixation system seems to be a promising concept of treatment.
Methods In this retrospective study, 14 patients with a mean age of 44 years (26-67 years) suffering from non-union (n=11) and/or malunion (n=4) of the clavicle were enrolled. All patients were surgically treated using an anatomical precontoured locking compression plate (LCP) and autologous iliac crest bone graft. Functional outcome was assessed using the age- and sex-specific relative Constant Score.
Read the detailed description
Methods
Patients and follow-up
All patients who were treated for clavicular non- or malunion with a locking compression plate and an iliac crest bone graft between January 2010 and December 2014 were included in this retrospective study. The study protocol was approved by the local ethics committee (71/15 S).
The preoperative symptoms included pain (n=12), limited range of motion (n=2), pain when sleeping on the affected side (n=2), skin irritation caused by dislocated screws (n=1), feeling of weakness of the arm (n=1) and crepitation (n=1).
Standard radiographs of the affected clavicle (anterior-posterior path of rays perpendicular to radiographic cassette, anterior-posterior path of rays 30° tilted cephalad) were performed at the time of the initial presentation of the patient as well as during the routine follow-up examinations in our outpatient clinic. Preoperative planning included the performance of a magnetic resonance imaging (MRI) scan to estimate the non-vital parts of bone to be resected as well as the performance of a computed tomography (CT) scan of both clavicles to measure the original clavicle length to be able to adequately decide if a bone graft would be required. A tricortical iliac crest bone graft was used in all cases with bony defects larger than 15 mm due to the risk of abnormal shoulder biomechanics following clavicular shortening possibly resulting in pain, shoulder motion impairment and loss of strength.
The Constant Score was used to assess the shoulder function and activity preoperatively as well as during the routine follow-up examinations in our outpatient clinic. Subsequently the original Constant Score values were converted according to Gerber et al. to receive a normative age- and sex-specific Constant Score (relative Constant Score).
The implant
The LCP (locking compression plate) superior anterior clavicle plate with lateral extension (Depuy) is an anatomically precontoured fixation system with three to eight medial shaft holes for 3.5 mm locking or 3.5 mm cortex screws and six lateral 2.7 mm divergent locking or 2.4 mm cortex screws. This implant was used for treatment of all enrolled patients.
Surgical technique and rehabilitation
All patients underwent surgery placed in a beachchair position with the affected arm in a mobile position. A longitudinal skin incision was set below the clavicle with subsequent incision through the clavi-pectoral fascia also in longitudinal direction to allow for a later closure to ensure sufficient soft tissue coverage. After exposure of the non- or malunion a complex multidimensional osteotomy of the clavicle with medial and lateral axial correction up to vital bone was performed. Vital bone was verified by local blood extravasation resulting from drilling the previously osteotomized bone segments. The tricortical iliac crest bone graft was harvested according to the size assessed in the preoperative CT scan, consecutively adapted to the intraoperative measured size of the bony defect. After implantation of the bone graft the LCP was centered onto the clavicular shaft. At least three screws should be placed medially and laterally to the bone graft to ensure sufficient biomechanical stability. Before drilling the screw holes the plate position was controlled by fluoroscopy. If necessary the iliac crest bone graft should additionally be fixed by a suture cerclage (Fiber- Wire, Arthrex). After a final radiographical examination the wound was closed layer by layer.
Regarding postoperative rehabilitation primarily the affected arm was immobilized in a sling for 6 weeks. Patients started physiotherapy on the first postoperative day following a standard rehabilitation protocol: abduction and flexion were restricted to 30° for the first two weeks, to 60° for the week three and four postoperative and to 90° for week five and six postoperative. Full weight bearing was not allowed before week 12 postoperative. 3, 6, 12 and 24 weeks postoperatively radiographs were performed to evaluate bone healing.
- Conditions
- Fracture, Healed, Fibrous Union
- Being tested
- LCP plus iliac crest autograft
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCP plus iliac crest autograftProcedure or surgery
After exposure of the non- or malunion a complex multidimensional osteotomy of the clavicle with medial and lateral axial correction up to vital bone was performed [14]. Vital bone was verified by local blood extravasation resulting from drilling the previously osteotomized bone segments. The tricortical iliac crest bone graft was harvested according to the size assessed in the preoperative CT scan, consecutively adapted to the intraoperative measured size of the bony defect. After implantation of the bone graft the LCP was centered onto the clavicular shaft.
| Study group | Role | What they receive |
|---|---|---|
| Nonunion group | All patients who were treated for clavicular non- or malunion with a locking compression plate and an iliac crest bone graft between January 2010 and December 2014 were included in this retrospective study. Receives: Procedure: LCP plus iliac crest autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Functional Outcome in comparison to preoperative state
Shoulder Function, assessed by MSQ
Measured: 1,5 yrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2014
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture, Healed, Fibrous UnionStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chlodwig Kirchhoff, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951468
- Sponsor's protocol ID
- Beiromat_04
- Acronym
- Nonunion
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2016
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No Plan
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-term Outcome Following Revision Surgery of Clavicular Non- and Malunion Using Anatomic Locking Compression Plate and Iliac Crest Bone Graft
- ClinicalTrials.gov ID
- NCT02951468
- Acronym / sponsor ID
- Nonunion / Beiromat_04
- Conditions
- Fracture, Healed, Fibrous Union
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Nov 2016 (estimated)
- 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.
Background Treatment of clavicular non- and malunion is still challenging. Current surgical procedures often result in partially frustrating functional outcome along with high-grade subjective impairment and increased rates of revision surgery. However, the combination of vital bone graft and a biomechanically sufficient fixation system seems to be a promising concept of treatment.
Methods In this retrospective study, 14 patients with a mean age of 44 years (26-67 years) suffering from non-union (n=11) and/or malunion (n=4) of the clavicle were enrolled. All patients were surgically treated using an anatomical precontoured locking compression plate (LCP) and autologous iliac crest bone graft. Functional outcome was assessed using the age- and sex-specific relative Constant Score.
Detailed description
Methods
Patients and follow-up
All patients who were treated for clavicular non- or malunion with a locking compression plate and an iliac crest bone graft between January 2010 and December 2014 were included in this retrospective study. The study protocol was approved by the local ethics committee (71/15 S).
The preoperative symptoms included pain (n=12), limited range of motion (n=2), pain when sleeping on the affected side (n=2), skin irritation caused by dislocated screws (n=1), feeling of weakness of the arm (n=1) and crepitation (n=1).
Standard radiographs of the affected clavicle (anterior-posterior path of rays perpendicular to radiographic cassette, anterior-posterior path of rays 30° tilted cephalad) were performed at the time of the initial presentation of the patient as well as during the routine follow-up examinations in our outpatient clinic. Preoperative planning included the performance of a magnetic resonance imaging (MRI) scan to estimate the non-vital parts of bone to be resected as well as the performance of a computed tomography (CT) scan of both clavicles to measure the original clavicle length to be able to adequately decide if a bone graft would be required. A tricortical iliac crest bone graft was used in all cases with bony defects larger than 15 mm due to the risk of abnormal shoulder biomechanics following clavicular shortening possibly resulting in pain, shoulder motion impairment and loss of strength.
The Constant Score was used to assess the shoulder function and activity preoperatively as well as during the routine follow-up examinations in our outpatient clinic. Subsequently the original Constant Score values were converted according to Gerber et al. to receive a normative age- and sex-specific Constant Score (relative Constant Score).
The implant
The LCP (locking compression plate) superior anterior clavicle plate with lateral extension (Depuy) is an anatomically precontoured fixation system with three to eight medial shaft holes for 3.5 mm locking or 3.5 mm cortex screws and six lateral 2.7 mm divergent locking or 2.4 mm cortex screws. This implant was used for treatment of all enrolled patients.
Surgical technique and rehabilitation
All patients underwent surgery placed in a beachchair position with the affected arm in a mobile position. A longitudinal skin incision was set below the clavicle with subsequent incision through the clavi-pectoral fascia also in longitudinal direction to allow for a later closure to ensure sufficient soft tissue coverage. After exposure of the non- or malunion a complex multidimensional osteotomy of the clavicle with medial and lateral axial correction up to vital bone was performed. Vital bone was verified by local blood extravasation resulting from drilling the previously osteotomized bone segments. The tricortical iliac crest bone graft was harvested according to the size assessed in the preoperative CT scan, consecutively adapted to the intraoperative measured size of the bony defect. After implantation of the bone graft the LCP was centered onto the clavicular shaft. At least three screws should be placed medially and laterally to the bone graft to ensure sufficient biomechanical stability. Before drilling the screw holes the plate position was controlled by fluoroscopy. If necessary the iliac crest bone graft should additionally be fixed by a suture cerclage (Fiber- Wire, Arthrex). After a final radiographical examination the wound was closed layer by layer.
Regarding postoperative rehabilitation primarily the affected arm was immobilized in a sling for 6 weeks. Patients started physiotherapy on the first postoperative day following a standard rehabilitation protocol: abduction and flexion were restricted to 30° for the first two weeks, to 60° for the week three and four postoperative and to 90° for week five and six postoperative. Full weight bearing was not allowed before week 12 postoperative. 3, 6, 12 and 24 weeks postoperatively radiographs were performed to evaluate bone healing.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonunion group | – | Procedure: LCP plus iliac crest autograftAll patients who were treated for clavicular non- or malunion with a locking compression plate and an iliac crest bone graft between January 2010 and December 2014 were included in this retrospective study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from clavicular non-unions or malunions
Key inclusion criteria (1 listed)
- clavicular non-unions or malunions
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| LCP plus iliac crest autograftAfter exposure of the non- or malunion a complex multidimensional osteotomy of the clavicle with medial and lateral axial correction up to vital bone was performed [14]. Vital bone was verified by local blood extravasation resulting from drilling the previously osteotomized bone segments. The tricortical iliac crest bone graft was harvested according to the size assessed in the preoperative CT scan, consecutively adapted to the intraoperative measured size of the bony defect. After implantation of the bone graft the LCP was centered onto the clavicular shaft. | Procedure or surgery | Nonunion group |
Primary outcome
Change of Functional Outcome in comparison to preoperative state
Time frame: 1,5 yrs.
Shoulder Function, assessed by MSQ
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 4 Nov 2016.
- Individual participant dataSharing planned: No. No Plan
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture, Healed, Fibrous Union, run by Technical University of Munich.
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 1 inclusion and 1 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Change of Functional Outcome in comparison to preoperative state (time frame: 1,5 yrs.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2016.