Shoulder
Locked intramedullary fixation vs plating for displaced and shortened mid-shaft clavicle fractures: A randomized clinical trial

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Background

Recent literature supports surgical intervention for shortened, displaced, mid-shaft clavicle fractures. We present the results of a randomized clinical trial comparing locked intramedullary fixation and plate fixation for short, displaced, mid-shaft clavicle fractures.

Materials and methods

Local ethical approval was obtained and power analysis and sample size calculations were performed prior to commencement. Patients randomized to 2 groups to be treated with either locked intramedullary fixation or plating. Patients regularly followed up to clinical and radiographic union. The primary outcome measure was the Constant score, secondary outcome measures included the Oxford shoulder score, union rate, and complication rates.

Results

Seventeen patients were randomized to locked intramedullary fixation and 15 randomized to plating. Mean age was 29.3years. Mean follow-up was 12.4 months. There was no significant difference in either Constant scores (P = .365) or Oxford scores (P = .773). There was 100% union in both groups. In the intramedullary group, 1 case of soft tissue irritation settled after the pin removal; 1 pin backed out and was revised. Three superficial wound infections resulted in plate removal and 8 plates (53%) were removed.

Discussion

Intramedullary fixation has the theoretical advantage of preserving the periosteal blood supply, but carries the morbidity of pin removal. Clavicle plates are not routinely removed but require greater exposure and may compromise periosteal blood supply.

Conclusion

Both locked intramedullary fixation and plating produce good functional results; however, metalwork may need to be removed as a second procedure.

Section snippets

Study design and ethics approval

Ethical approval for the study was granted by both regional and trust ethics comities. Ethical approval was initially granted for a study with 3 treatment groups: conservative, Rockwood Pin, and plating.

This is a randomized clinical trial of patients with shortened, displaced, mid-shaft clavicle fractures, treated at a tertiary referral center by 2 consultants with specialist interest in upper limb surgery between 2006 and 2008.

During the study period, 880 patients were referred to our unit

Results

During the study period, 32 patients were recruited to the trial: 17 randomized to Rockwood Pin and 15 randomized to plating. There were 27 males and 5 females recruited, with a mean age of 29.3years (range, 13-53).The mean time to surgery for the group was 1 week (range, 1-6). The delay to surgery was due to delay in referral from other centres or waiting for available theatre time. Surgery was performed by 2 specialist shoulder surgeons. Mean time to follow-up was 12.4 months (range, 5-28).

Discussion

In this study, shortened and displaced mid-shaft clavicle fractures, treated with either Rockwood Pin or plating, achieved a 100% union rate, with no major complications and avoidance of the symptoms of mal-union such as pain and weakness.

This is a relatively small series of cases treated at a tertiary referral center with mean follow-up of 1 year. While a computer was not used for randomization, a 1:1 ratio of envelopes was used for randomization. Although the follow-up was relatively short,

Conclusions

Our results provide evidence that shortened and displaced mid-shaft clavicle fractures when treated operatively achieve good functional results. While the outcome scores of Rockwood Pin fixation were higher than those for plating, the differences were not statistically significant. Rockwood Pins require operative removal after fracture union; however, in our study, 53% of plates had to be removed due to soft tissue irritation. The incision used for pin fixation involves less soft tissue

Acknowledgment

The authors would like to acknowledge the significant contributions of Physiotherapy Assistant Jacqueline Brown for scoring patients, and Physiotherapists Ann Wilkes and Denise Jones for supervising the rehabilitation of patients.

Disclaimer

No author, their immediate family, and any research foundation with which they are affiliated have received any financial payments or other benefits from any commercial entity related to the subject of this article.

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Ethical Approval: Ethical approval for the study was granted by both South Wales Research Ethics Committee and trust ethics comities (05/WSE04/161).

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