Patients With Closed Neer Type 4 Proximal Humerus FracturesNCT04995744

Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures

A study testing Pectoralis Major Pedicle Bone Graft in people with Patients With Closed Neer Type 4 Proximal Humerus Fractures, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The investigators tried to evaluate the results of our patients who underwent plate osteosynthesis with vascularized pectoralis major graft for the treatment of 4-part proximal humerus fractures. Read more about this study

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Patients With Closed Neer Type 4 Proximal Humerus Fractures
What is being tested?: Pectoralis Major Pedicle Bone Graft
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2017to 1 Feb 2020
Phase: Interventional
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 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients aged 50-75 years with closed Neer type 4 proximal humerus fractures

Who cannot join

Patients under 50 and over 75 years of age,
Patients with pathological fractures,
Patients with neurological deficits such as brachial plexus injury
Patients with previous shoulder surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

SBU Prof. Cemil Tascioglu City Hospital
Istanbul, 34040

Other trials in Turkey (Türkiye)

About this study

The investigators tried to evaluate the results of our patients who underwent plate osteosynthesis with vascularized pectoralis major graft for the treatment of 4-part proximal humerus fractures.

Read the detailed description

The risk of avascular necrosis, nonunion, or malunion is high in 4-part fractures which is the most serious form of proximal humerus fracture.Bone impaction grafts are an important treatment option when osteosynthesis with LCP plate is desired especially for osteoporotic patients. Fibular strut grafts (FSGs) and autologous iliac bone impaction grafts (AIBIGs), which are frequently used to provide mechanical support, may have the risk of nonunion in osteoporotic bone whose vascular support is weakened due to fracture. Bone pedicled pectoralis major grafts may prevent varus collapse, nonunion and avascular necrosis.

Conditions: Patients With Closed Neer Type 4 Proximal Humerus Fractures
Being tested: Pectoralis Major Pedicle Bone Graft
Keywords: proximal humerus, closed, fracture, bone pedicled graft
Medical subject headings: Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pectoralis Major Pedicle Bone GraftProcedure or surgery
It is aimed to restore the integrity of the medial cortex with the bone pedicle from the insertion region of the pectoralis major muscle in middle-aged patients with Neer type 4 proximal humerus fractures. Researchers aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method. The investigators aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method.

Study groups in NCT04995744
Study group	Role	What they receive
Patients with closed Neer type 4 proximal humerus fractures	Other	patients aged 50-75 years with closed Neer type 4 proximal humerus fractures Receives: Procedure: Pectoralis Major Pedicle Bone Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

Patients were evaluated in terms of functional shoulder results and radiographic union
Constant and American shoulder and elbow surgeons scores were used for functional assesment
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20171 Feb 2020

First posted9 Aug 2021
Study start1 Jan 2017
Primary completion30 Jan 2020
Study completion1 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Patients With Closed Neer Type 4 Proximal Humerus FracturesStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04995744
Sponsor's protocol ID: Pectoralis Major Pedicle Graft
Status last verified: Jul 2021
First submitted: 30 Jul 2021
Last updated: 9 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fialka C, Stampfl P, Arbes S, Reuter P, Oberleitner G, Vecsei V. Primary hemiarthroplasty in four-part fractures of the proximal humerus: randomized trial of two different implant systems. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):210-5. doi: 10.1016/j.jse.2007.07.002. Epub 2007 Oct 10.
PubMed 17931895
Kim SH, Lee YH, Chung SW, Shin SH, Jang WY, Gong HS, Baek GH. Outcomes for four-part proximal humerus fractures treated with a locking compression plate and an autologous iliac bone impaction graft. Injury. 2012 Oct;43(10):1724-31. doi: 10.1016/j.injury.2012.06.029. Epub 2012 Jul 20.
PubMed 22819250
Palvanen M, Kannus P, Niemi S, Parkkari J. Update in the epidemiology of proximal humeral fractures. Clin Orthop Relat Res. 2006 Jan;442:87-92. doi: 10.1097/01.blo.0000194672.79634.78.
PubMed 16394745
Konrad G, Bayer J, Hepp P, Voigt C, Oestern H, Kaab M, Luo C, Plecko M, Wendt K, Kostler W, Sudkamp N. Open reduction and internal fixation of proximal humeral fractures with use of the locking proximal humerus plate. Surgical technique. J Bone Joint Surg Am. 2010 Mar;92 Suppl 1 Pt 1:85-95. doi: 10.2106/JBJS.I.01462.
PubMed 20194347
Clavert P, Adam P, Bevort A, Bonnomet F, Kempf JF. Pitfalls and complications with locking plate for proximal humerus fracture. J Shoulder Elbow Surg. 2010 Jun;19(4):489-94. doi: 10.1016/j.jse.2009.09.005. Epub 2009 Dec 7.
PubMed 19995683
Neer CS 2nd. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am. 1970 Sep;52(6):1077-89. No abstract available.
PubMed 5455339
Gallo RA, Sciulli R, Daffner RH, Altman DT, Altman GT. Defining the relationship between rotator cuff injury and proximal humerus fractures. Clin Orthop Relat Res. 2007 May;458:70-7. doi: 10.1097/BLO.0b013e31803bb400.
PubMed 17308477
Choo A, Sobol G, Maltenfort M, Getz C, Abboud J. Prevalence of rotator cuff tears in operative proximal humerus fractures. Orthopedics. 2014 Nov;37(11):e968-74. doi: 10.3928/01477447-20141023-52.
PubMed 25361372
Kim SH, Szabo RM, Marder RA. Epidemiology of humerus fractures in the United States: nationwide emergency department sample, 2008. Arthritis Care Res (Hoboken). 2012 Mar;64(3):407-14. doi: 10.1002/acr.21563.
PubMed 22162357
Adeyemo A, Bertha N, Perry KJ, Updegrove G. Implant Selection for Proximal Humerus Fractures. Orthop Clin North Am. 2021 Apr;52(2):167-175. doi: 10.1016/j.ocl.2020.12.008. Epub 2021 Feb 10.
PubMed 33752838
Hardeman F, Bollars P, Donnelly M, Bellemans J, Nijs S. Predictive factors for functional outcome and failure in angular stable osteosynthesis of the proximal humerus. Injury. 2012 Feb;43(2):153-8. doi: 10.1016/j.injury.2011.04.003. Epub 2011 May 12.
PubMed 21570073
Laflamme GY, Moisan P, Chapleau J, Goulet J, Leduc S, Benoit B, Rouleau DM. Novel Technical Factors Affecting Proximal Humerus Fixation Stability. J Orthop Trauma. 2021 May 1;35(5):259-264. doi: 10.1097/BOT.0000000000001984.
PubMed 33165208
Voigt C, Kreienborg S, Megatli O, Schulz AP, Lill H, Hurschler C. How does a varus deformity of the humeral head affect elevation forces and shoulder function? A biomechanical study with human shoulder specimens. J Orthop Trauma. 2011 Jul;25(7):399-405. doi: 10.1097/BOT.0b013e31820beb80.
PubMed 21637119
Krappinger D, Bizzotto N, Riedmann S, Kammerlander C, Hengg C, Kralinger FS. Predicting failure after surgical fixation of proximal humerus fractures. Injury. 2011 Nov;42(11):1283-8. doi: 10.1016/j.injury.2011.01.017. Epub 2011 Feb 9.
PubMed 21310406
Katthagen JC, Schwarze M, Meyer-Kobbe J, Voigt C, Hurschler C, Lill H. Biomechanical effects of calcar screws and bone block augmentation on medial support in locked plating of proximal humeral fractures. Clin Biomech (Bristol). 2014 Aug;29(7):735-41. doi: 10.1016/j.clinbiomech.2014.06.008. Epub 2014 Jun 19.
PubMed 24997810

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures
ClinicalTrials.gov ID: NCT04995744
Acronym / sponsor ID: Pectoralis Major Pedicle Graft
Conditions: Patients With Closed Neer Type 4 Proximal Humerus Fractures
Keywords: proximal humerus, closed, fracture, bone pedicled graft
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
Study start: 1 Jan 2017 (actual)
Primary completion: 30 Jan 2020 (actual)
Study completion: 1 Feb 2020 (actual)
First posted: 9 Aug 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 investigators tried to evaluate the results of our patients who underwent plate osteosynthesis with vascularized pectoralis major graft for the treatment of 4-part proximal humerus fractures.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with closed Neer type 4 proximal humerus fractures	Other	Procedure: Pectoralis Major Pedicle Bone Graftpatients aged 50-75 years with closed Neer type 4 proximal humerus fractures

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

patients aged 50-75 years with closed Neer type 4 proximal humerus fractures

Key exclusion criteria (4 listed)

Patients under 50 and over 75 years of age,
Patients with pathological fractures,
Patients with neurological deficits such as brachial plexus injury
Patients with previous shoulder surgery

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
Pectoralis Major Pedicle Bone GraftIt is aimed to restore the integrity of the medial cortex with the bone pedicle from the insertion region of the pectoralis major muscle in middle-aged patients with Neer type 4 proximal humerus fractures. Researchers aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method. The investigators aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method.	Procedure or surgery	Patients with closed Neer type 4 proximal humerus fractures

Primary outcome

Patients were evaluated in terms of functional shoulder results and radiographic union
Time frame: 2 years
Constant and American shoulder and elbow surgeons scores were used for functional assesment

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 9 Aug 2021.
Background: PubMed 17931895Fialka C, Stampfl P, Arbes S, Reuter P, Oberleitner G, Vecsei V. Primary hemiarthroplasty in four-part fractures of the proximal humerus: randomized trial of two different implant systems. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):210-5. doi: 10.1016/j.jse.2007.07.002. Epub 2007 Oct 10.
Results publication: PubMed 22819250Kim SH, Lee YH, Chung SW, Shin SH, Jang WY, Gong HS, Baek GH. Outcomes for four-part proximal humerus fractures treated with a locking compression plate and an autologous iliac bone impaction graft. Injury. 2012 Oct;43(10):1724-31. doi: 10.1016/j.injury.2012.06.029. Epub 2012 Jul 20.
Results publication: PubMed 16394745Palvanen M, Kannus P, Niemi S, Parkkari J. Update in the epidemiology of proximal humeral fractures. Clin Orthop Relat Res. 2006 Jan;442:87-92. doi: 10.1097/01.blo.0000194672.79634.78.
Results publication: PubMed 20194347Konrad G, Bayer J, Hepp P, Voigt C, Oestern H, Kaab M, Luo C, Plecko M, Wendt K, Kostler W, Sudkamp N. Open reduction and internal fixation of proximal humeral fractures with use of the locking proximal humerus plate. Surgical technique. J Bone Joint Surg Am. 2010 Mar;92 Suppl 1 Pt 1:85-95. doi: 10.2106/JBJS.I.01462.
Results publication: PubMed 19995683Clavert P, Adam P, Bevort A, Bonnomet F, Kempf JF. Pitfalls and complications with locking plate for proximal humerus fracture. J Shoulder Elbow Surg. 2010 Jun;19(4):489-94. doi: 10.1016/j.jse.2009.09.005. Epub 2009 Dec 7.
Results publication: PubMed 5455339Neer CS 2nd. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am. 1970 Sep;52(6):1077-89. No abstract available.
Results publication: PubMed 17308477Gallo RA, Sciulli R, Daffner RH, Altman DT, Altman GT. Defining the relationship between rotator cuff injury and proximal humerus fractures. Clin Orthop Relat Res. 2007 May;458:70-7. doi: 10.1097/BLO.0b013e31803bb400.
Results publication: PubMed 25361372Choo A, Sobol G, Maltenfort M, Getz C, Abboud J. Prevalence of rotator cuff tears in operative proximal humerus fractures. Orthopedics. 2014 Nov;37(11):e968-74. doi: 10.3928/01477447-20141023-52.
Results publication: PubMed 22162357Kim SH, Szabo RM, Marder RA. Epidemiology of humerus fractures in the United States: nationwide emergency department sample, 2008. Arthritis Care Res (Hoboken). 2012 Mar;64(3):407-14. doi: 10.1002/acr.21563.
Results publication: PubMed 33752838Adeyemo A, Bertha N, Perry KJ, Updegrove G. Implant Selection for Proximal Humerus Fractures. Orthop Clin North Am. 2021 Apr;52(2):167-175. doi: 10.1016/j.ocl.2020.12.008. Epub 2021 Feb 10.
Results publication: PubMed 21570073Hardeman F, Bollars P, Donnelly M, Bellemans J, Nijs S. Predictive factors for functional outcome and failure in angular stable osteosynthesis of the proximal humerus. Injury. 2012 Feb;43(2):153-8. doi: 10.1016/j.injury.2011.04.003. Epub 2011 May 12.
Results publication: PubMed 33165208Laflamme GY, Moisan P, Chapleau J, Goulet J, Leduc S, Benoit B, Rouleau DM. Novel Technical Factors Affecting Proximal Humerus Fixation Stability. J Orthop Trauma. 2021 May 1;35(5):259-264. doi: 10.1097/BOT.0000000000001984.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 9 Aug 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 Turkey (Türkiye). 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.

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?

Patients were evaluated in terms of functional shoulder results and radiographic union (time frame: 2 years). 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 NCT04995744, which also lists 30 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 9 Aug 2021.