Session IV - Upper Extremity

Fri., 10/9/09 Upper Extremity, Paper #54, 12:20 pm OTA-2009

Do Antioxidants Modulate the Outcome of Fractures? A Prospective Randomized Controlled Trial
(FDA=Non-U.S. research conducted within guidelines of my country)

Ingri Ekrol, MD1 (n); Charles Court-Brown, MD1 (n); Stuart Ralston, MD2 (n);
Margaret McQueen, MD1 (n);
1Orthopaedic Trauma Unit, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom;
2University of Edinburgh, Edinburgh, United Kingdom

Purpose: This study was designed to examine the effect of vitamin C on hand and wrist function, the incidence of complex regional pain syndrome (CRPS), and the rate of fracture healing following fracture of the distal radius.

Methods: A prospective, randomized double-blind controlled trial was performed on 336 patients. After informed consent, patients were randomized to receive either 500 mg vitamin C or a placebo for 50 days, starting on the day after fracture. The groups were stratified into displaced and undisplaced fractures. The study did not alter the treatment method. Clinical, functional, and radiological evaluations were carried out at 2, 6, 12, 26, and 52 weeks. The primary outcome was the Disability of the Arm, Shoulder and Hand (DASH) score. CRPS was diagnosed and scored using the criteria described by Atkins. Functional evaluations included measurement of pain, active range of movement, and grip and pinch strength. Bone healing was assessed by cortical bridging and trabeculae crossing the fracture site.

Results: There were no differences in the DASH score at any of the time intervals for either displaced or undisplaced fractures. There were a few statistically significant differences in the testing of movement and strength, but none of these were clinically significant and all showed worse outcomes in the vitamin C group. In patients with undisplaced fractures, there was a statistically significantly higher rate of CRPS treated with vitamin C at 6 weeks (P = 0.022), but no other differences in the rate of CRPS at any time point. There were no differences in the time to bone healing between the groups. In the displaced fracture group treated with vitamin C, there was a significantly higher rate of complications (P = 0.043) and worse pain on activity (P = 0.045) at 26 weeks, but no other significant differences between the groups.

Conclusion: This study showed that vitamin C does not improve the patient-rated outcome, range of movement, strength, rate of CRPS, or bone healing after distal radius fractures and questions the previous evidence of an advantageous effect of vitamin C administration after wrist fracture.

Disclosure: (n=Respondent answered 'No' to all items indicating no conflicts; 1=Board member/owner/officer/committee appointments; 2=Medical/Orthopaedic Publications; 3=Royalties; 4=Speakers bureau/paid presentations; 5A=Paid consultant or employee; 5B=Unpaid consultant; 6=Research or institutional support from a publisher; 7=Research or institutional support from a company or supplier; 8=Stock or Stock Options; 9=Other financial/material support from a publisher; 10=Other financial/material support from a company or supplier).

• The FDA has not cleared this drug and/or medical device for the use described in this presentation   (i.e., the drug or medical device is being discussed for an “off label” use).  ◆FDA information not available at time of printing. Δ OTA Grant