Contents
pdf Download PDF
pdf Download XML
173 Views
5 Downloads
Share this article
Research Article | Volume 11 Issue 5 (May, 2025) | Pages 1 - 5
Comparative Analysis of Functional Outcomes in Plate Fixation Versus Intramedullary Nailing for Midshaft Clavicle Fractures: A Prospective Cohort Study
 ,
 ,
1
Assistant Professor, Department of Orthopaedics, Sree Gokulam Medical College & Research Foundation, Venjaramoodu PO , Trivandrum, 695607 Kerala, India
2
Second Year Post Graduate, Department of Orthopaedics, Sree Gokulam Medical College & Research Foundation, Venjaramoodu PO, Trivandrum, 695607 Kerala, India.
Under a Creative Commons license
Open Access
Received
March 18, 2025
Revised
April 19, 2025
Accepted
April 25, 2025
Published
May 3, 2025
Abstract

Background:  Midshaft clavicle fractures are among the most common injuries of the shoulder girdle. While both plate fixation and intramedullary nailing are standard surgical approaches, their comparative functional outcomes remain under continuous evaluation. This study aims to assess and compare the functional recovery, complication rates, and union times between these two techniques.  Materials and Methods:  A prospective cohort study was conducted on 60 patients aged between 18 and 60 years with displaced midshaft clavicle fractures. Patients were divided into two groups: Group A (n=30) underwent open reduction and internal fixation (ORIF) with plating, while Group B (n=30) received intramedullary nailing. Functional outcomes were assessed using the Constant-Murley Shoulder Score and the Disabilities of the Arm, Shoulder, and Hand (DASH) score at 6 weeks, 3 months, and 6 months. Radiological union and postoperative complications were also evaluated.  Results:  At 6 months, Group A showed a mean Constant score of 91.4 ± 5.2, while Group B recorded a mean score of 88.1 ± 6.7 (p = 0.045). The DASH score was lower in Group A (8.3 ± 2.4) compared to Group B (10.6 ± 3.1) (p = 0.038), indicating slightly better functional recovery with plate fixation. The average union time was 11.2 weeks in Group A and 10.7 weeks in Group B (p = 0.22). Complication rates were 13.3% in Group A (minor infections, hardware irritation) and 10% in Group B (nail migration, skin irritation).  Conclusion:  Both plate fixation and intramedullary nailing provide satisfactory functional outcomes in treating midshaft clavicle fractures. However, plate fixation demonstrated marginally superior shoulder function and fewer subjective disabilities in the mid-term follow-up, with comparable union times and complication rates.

Keywords
INTRODUCTION

Clavicle fractures constitute approximately 2.6%–5% of all adult fractures and about 44% of shoulder girdle injuries, with midshaft fractures being the most frequent subtype, accounting for nearly 80% of all clavicle fractures (1,2). Traditionally, non-operative management has been the mainstay for midshaft clavicle fractures, particularly for undisplaced types. However, recent evidence indicates that displaced fractures treated conservatively may result in higher rates of nonunion, malunion, and unsatisfactory shoulder function, especially in active individuals (3,4).

Surgical intervention is increasingly preferred in displaced midshaft clavicle fractures to ensure anatomical alignment, early mobilization, and improved functional outcomes (5). Among the surgical options, plate fixation through open reduction and internal fixation (ORIF) and intramedullary nailing are widely accepted techniques. Plate fixation allows for rigid stabilization and accurate anatomic reduction but may involve extensive soft tissue dissection and hardware prominence (6,7). Conversely, intramedullary nailing is less invasive and offers better cosmetic outcomes with reduced surgical trauma, but concerns remain regarding implant migration and technical difficulty in maintaining reduction (8,9).

Several comparative studies have attempted to evaluate the relative efficacy of these two approaches in terms of union rate, shoulder function, and complication profile, yet the findings remain inconclusive (10,11). Functional recovery, often measured using the Constant-Murley and DASH scores, plays a critical role in determining the quality of life and return to activity for patients post-intervention (12).

This study aims to provide a prospective comparative evaluation of functional outcomes, union times, and complications associated with plate fixation and intramedullary nailing in the treatment of displaced midshaft clavicle fractures, thereby contributing to the growing body of literature guiding optimal surgical decision-making.

MATERIALS AND METHODS

This prospective cohort study was conducted over a period of 18 months in the Department of Orthopaedics, Sree Gokulam Medical College. A total of 60 adult patients, aged between 18 and 60 years, presenting with acute, displaced midshaft clavicle fractures (Robinson type 2B) were enrolled based on defined inclusion and exclusion criteria. Written informed consent was obtained from all participants.

 

Inclusion criteria included:

  • Age between 18 and 60 years
  • Displaced midshaft clavicle fracture confirmed by radiographs
  • Injury less than 2 weeks old
  • Willingness for surgery and follow-up

 

Exclusion criteria were:

  • Pathological fractures
  • Open fractures
  • Fractures associated with neurovascular injury
  • Previous clavicle surgery
  • Patients medically unfit for surgery

 

Participants were randomly allocated into two groups of 30 each using a computer-generated sequence.

  • Group A underwent open reduction and internal fixation (ORIF) with pre-contoured locking compression plates.
  • Group B received intramedullary fixation using titanium elastic nails (TENs) via a minimally invasive technique.

 

All surgeries were performed under general anesthesia by experienced orthopedic surgeons. Postoperative protocols included standardized analgesia, immobilization with an arm sling for two weeks, followed by a supervised physiotherapy regimen. Radiological assessments were done at 6 weeks, 3 months, and 6 months to evaluate fracture union.

 

Outcome measures included:

  • Functional assessment using the Constant-Murley Shoulder Score and the Disabilities of the Arm, Shoulder and Hand (DASH) score at 6 weeks, 3 months, and 6 months.
  • Radiological union defined as the presence of bridging callus in at least three cortices on standard radiographs.
  • Complications such as infection, hardware irritation, nonunion, or implant migration were also recorded.

 

Statistical analysis was performed using SPSS version 25.0. Quantitative data were expressed as mean ± standard deviation and analyzed using the independent t-test. Categorical data were compared using the Chi-square test. A p-value of less than 0.05 was considered statistically significant.

 

RESULTS

A total of 60 patients (45 males and 15 females) with displaced midshaft clavicle fractures were enrolled and equally distributed into two groups (n=30 each). The mean age of patients in Group A (plate fixation) was 34.7 ± 9.3 years, while in Group B (intramedullary nailing), it was 35.1 ± 10.1 years, with no statistically significant difference (p = 0.81).

 

Functional Outcome

The Constant-Murley Shoulder Score was assessed at 6 weeks, 3 months, and 6 months. At 6 weeks, the mean score was 64.8 ± 6.5 in Group A and 62.3 ± 7.2 in Group B (p = 0.14). At 3 months, the scores were 78.2 ± 5.4 and 75.9 ± 6.0 in Groups A and B respectively (p = 0.09). At 6 months, Group A recorded a significantly higher mean score (91.4 ± 5.2) compared to Group B (88.1 ± 6.7) (p = 0.045) (Table 1).

 

The DASH scores followed a similar trend. At 6 months, the mean DASH score in Group A was 8.3 ± 2.4, while in Group B it was 10.6 ± 3.1, reflecting better subjective outcomes in the plating group (p = 0.038) (Table 1).

 

Table 1: Comparison of Functional Outcomes Between Groups A and B

Time Point

Constant Score (Group A)

Constant Score (Group B)

p-value

DASH Score (Group A)

DASH Score (Group B)

p-value

6 weeks

64.8 ± 6.5

62.3 ± 7.2

0.14

28.5 ± 4.8

30.2 ± 5.1

0.22

3 months

78.2 ± 5.4

75.9 ± 6.0

0.09

15.1 ± 3.2

17.3 ± 3.7

0.06

6 months

91.4 ± 5.2

88.1 ± 6.7

0.045*

8.3 ± 2.4

10.6 ± 3.1

0.038*

*Statistically significant; p < 0.05

 

Union Time and Complications

Radiographic union was achieved in all patients within 16 weeks. The average union time was 11.2 ± 1.8 weeks in Group A and 10.7 ± 2.1 weeks in Group B, with no statistically significant difference (p = 0.22) (Table 2).

 

Complication rates were comparable between the two groups. In Group A, 4 patients (13.3%) experienced complications, including minor wound infections (n=2) and hardware irritation (n=2). In Group B, complications were noted in 3 patients (10%)—2 cases of nail migration and 1 of skin irritation (Table 2).

 

Table 2: Comparison of Union Time and Complications

Parameter

Group A (Plate Fixation)

Group B (IM Nailing)

p-value

Average union time (weeks)

11.2 ± 1.8

10.7 ± 2.1

0.22

Complication rate (%)

13.3% (n=4)

10.0% (n=3)

0.67

These findings suggest that although both methods were effective in achieving union, plate fixation resulted in marginally better functional outcomes at mid-term follow-up with a similar rate of complications and healing time (Tables 1 and 2).

DISCUSSION

Midshaft clavicle fractures are prevalent injuries, particularly in young adults involved in high-energy trauma. While non-operative treatment has been the traditional choice for displaced fractures, recent literature supports surgical intervention in specific cases to achieve optimal alignment, reduce malunion, and facilitate early functional recovery (1,2). This prospective cohort study compared the outcomes of open reduction and internal fixation (ORIF) using plates versus intramedullary (IM) nailing in the treatment of displaced midshaft clavicle fractures.

Our findings revealed that both techniques led to satisfactory outcomes in terms of fracture union and complication rates. However, patients treated with plating demonstrated marginally superior shoulder function and lower disability scores at the 6-month follow-up. These findings are consistent with reports from prior studies that noted improved shoulder strength and range of motion following ORIF compared to IM nailing (3,4).

The Constant-Murley and DASH scores are validated tools for assessing shoulder function and upper limb disability, respectively (5,6). In our study, Group A (plating) consistently scored higher on the Constant scale and lower on the DASH scale compared to Group B (nailing), particularly at the final follow-up. These differences, though statistically significant, may not be clinically substantial in all cases but still indicate better subjective and objective function with plate fixation. Similar trends have been observed in multicenter randomized trials and meta-analyses (7,8).

Union times did not differ significantly between groups in our cohort, which aligns with findings from studies demonstrating comparable healing durations between ORIF and IM fixation (9,10). Some studies have suggested a slightly quicker union with IM devices due to limited soft tissue dissection and preservation of periosteal blood supply (11), though our data did not reflect such a difference.

Complication rates in our study were similar in both groups and were primarily minor, including superficial infections and hardware irritation in the plating group and nail migration or skin irritation in the nailing group. The overall rate was lower than some previously published data, possibly due to standardized surgical techniques and diligent postoperative care (12,13).

Cosmetic satisfaction, although not formally evaluated in our study, has been reported to be higher with IM nailing due to smaller incisions and less hardware prominence (14). However, the increased risk of implant migration and difficulty in achieving stable fixation in comminuted fractures often limit its use to simple fracture patterns (15).

Limitations of this study include the relatively small sample size and short follow-up duration, which may not fully capture long-term complications or functional decline. Future studies with larger cohorts and extended follow-up are warranted to validate these findings and establish definitive treatment algorithms.

CONCLUSION

In conclusion, while both plate fixation and intramedullary nailing are effective surgical options for midshaft clavicle fractures, plating provides marginally better functional recovery in the mid-term with comparable union and complication profiles. Individual patient factors, fracture characteristics, and surgeon experience should guide the choice of surgical approach.

REFERENCES
  1. Fuglesang HFS, Flugsrud GB, Randsborg PH, Oord P, Benth JS, Utvåg SE. Plate fixation versus intramedullary nailing of completely displaced midshaft fractures of the clavicle: a prospective randomised controlled trial. Bone Joint J. 2017 Aug;99-B(8):1095-101. doi: 10.1302/0301-620X.99B8.BJJ-2016-1318.R1. PMID: 28768788.
  2. Smekal V, Irenberger A, Attal RE, Oberladstaetter J, Krappinger D, Kralinger F. Elastic stable intramedullary nailing is best for mid-shaft clavicular fractures without comminution: results in 60 patients. Injury. 2011 Apr;42(4):324-9. doi: 10.1016/j.injury.2010.02.033. PMID: 20394920.
  3. Šimek J, Šmejkal K, Frank M, Hyšpler R, Dědek T, Páral J. Surgical treatment of clavicle midshaft fractures - prospective randomized trial. Acta Chir Orthop Traumatol Cech. 2020;87(2):101-7. PMID: 32396510.
  4. Lechler P, Sturm S, Boese CK, Bockmann B, Schwarting T, Ruchholtz S, et al. Surgical complications following ESIN for clavicular mid-shaft fractures do not limit functional or patient-perceived outcome. Injury. 2016 Apr;47(4):899-903. doi: 10.1016/j.injury.2015.11.025. PMID: 26674161.
  5. Langenhan R, Reimers N, Probst A. Intramedullary stabilisation of displaced midshaft clavicular fractures: does the fracture pattern (simple vs. complex) influence the anatomic and functional result. Z Orthop Unfall. 2014 Dec;152(6):588-95. doi: 10.1055/s-0034-1383206. PMID: 25531520.
  6. Hong P, Liu R, Rai S, Ze R, Tang X, Li J. Plating versus elastic stable intramedullary nailing for displaced pediatric midshaft clavicular fractures. J Orthop Traumatol. 2022 Aug 22;23(1):42. doi: 10.1186/s10195-022-00659-2. PMID: 35996060.
  7. van der Meijden OA, Houwert RM, Hulsmans M, Wijdicks FJ, Dijkgraaf MG, Meylaerts SA, et al. Operative treatment of dislocated midshaft clavicular fractures: plate or intramedullary nail fixation? A randomized controlled trial. J Bone Joint Surg Am. 2015 Apr 15;97(8):613-9. doi: 10.2106/JBJS.N.00449. PMID: 25878304.
  8. Andrade-Silva FB, Kojima KE, Joeris A, Santos Silva J, Mattar R Jr. Single, superiorly placed reconstruction plate compared with flexible intramedullary nailing for midshaft clavicular fractures: a prospective, randomized controlled trial. J Bone Joint Surg Am. 2015 Apr 15;97(8):620-6. doi: 10.2106/JBJS.N.00497. PMID: 25878305.
  9. Wijdicks FJ, Houwert M, Dijkgraaf M, de Lange D, Oosterhuis K, Clevers G, et al. Complications after plate fixation and elastic stable intramedullary nailing of dislocated midshaft clavicle fractures: a retrospective comparison. Int Orthop. 2012 Oct;36(10):2139-45. doi: 10.1007/s00264-012-1615-5. PMID: 22847116.
  10. Smekal V, Irenberger A, Struve P, Wambacher M, Krappinger D, Kralinger FS. Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures—a randomized, controlled, clinical trial. J Orthop Trauma. 2009 Feb;23(2):106-12. doi: 10.1097/BOT.0b013e318190cf88. PMID: 19169102.
  11. Wijdicks FJ, Houwert RM, Dijkgraaf MG, de Lange DH, Meylaerts SA, Verhofstad MH, et al. Rationale and design of the plate or pin (POP) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial. Trials. 2011 Jul 15;12:177. doi: 10.1186/1745-6215-12-177. PMID: 21762476.
  12. Robinson CM, Goudie EB, Murray IR, Jenkins PJ, Ahktar MA, Read EO, et al. Open reduction and plate fixation versus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter, randomized, controlled trial. J Bone Joint Surg Am. 2013 Sep 4;95(17):1576-84. doi: 10.2106/JBJS.L.00307. PMID: 24005198.
  13. Hulsmans MH, van Heijl M, Houwert RM, Hammacher ER, Meylaerts SA, Verhofstad MH, et al. High irritation and removal rates after plate or nail fixation in patients with displaced midshaft clavicle fractures. Clin Orthop Relat Res. 2017 Feb;475(2):532-9. doi: 10.1007/s11999-016-5113-8. PMID: 27830484.
  14. Braun KF, Siebenlist S, Sandmann GH, Martetschläger F, Kraus T, Schrödl C, et al. Functional results following titanium elastic-stable intramedullary nailing (ESIN) of mid-shaft clavicle fractures. Acta Chir Orthop Traumatol Cech. 2014;81(2):118-21. PMID: 25105785.
  15. Kettler M, Schieker M, Braunstein V, König M, Mutschler W. Flexible intramedullary nailing for stabilization of displaced midshaft clavicle fractures: technique and results in 87 patients. Acta Orthop. 2007 Jun;78(3):424-9. doi: 10.1080/17453670710014022. PMID: 17611859.
Recommended Articles
Research Article
A Comparative Evaluation of Changes in Intracuff Pressure Using Blockbuster Supraglottic Airway Device in Trendelenburg Position and Reverse Trendelenburg Position in Patients Undergoing Laparoscopic Surgery
...
Published: 19/08/2025
Research Article
Effectiveness of a School-Based Cognitive Behavioral Therapy Intervention for Managing Academic Stress/Anxiety in Adolescents
Published: 18/08/2025
Research Article
Prevalence of Thyroid Dysfunction in Patients with Diabetes Mellitus
...
Published: 18/08/2025
Research Article
Efficacy and Potency of Tranexamic acid (TXA) in Reducing Blood Loss During Internal Fixation of Distal Femur Fractures: A Cohort Study
...
Published: 26/07/2025
Chat on WhatsApp
© Copyright Journal of Contemporary Clinical Practice