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Hip screw and plate system had no clinical treatment effect on intracapsular fractures
Researchers are now expanding their pilot study of the system to a full trial.
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A novel hip screw and plate system was not clinically effective as an intracapsular hip fracture treatment method, according to results of a pilot randomized controlled trial.
“[There was] no evidence of a clinical benefit, but we cannot exclude a clinically important benefit or harm,” Xavier L. Griffin, MA MSc MRCS, a Specialist Registrar (T&O) at Warwick Medical School, Warwick University, in the United Kingdom, told Orthopaedics Today Europe. “We have expanded the trial to try and confirm the effect size.”
The Targon FN system (BBraun Melsungen AG; Melsungen, Germany) has elements of a dynamic hip screw or sliding hip screw, and cannulated screws. The implant has a locking plate, fixed-angle telescoping screws and two locking screws fix the plate to the subtrochanteric region. The telescoping screws do not prolapse into the lateral soft tissues, and the rotationally stable construct limits loss of reduction of the femoral head, Griffin said in his presentation at the 13th EFORT Congress 2012 in Berlin.
But, he noted, there was no evidence of the system’s clinical effectiveness.
Pilot investigation
This study was the pilot arm of a three-arm, single center, standard-of-care controlled, participant double-blinded, randomized trial. Between September 2009 and March 2011, the researchers recruited 125 patients older than 65 years with displaced or undisplaced intracapsular hip fractures.
Griffin and colleagues randomized the patients via a web-based portal. The test group included 25 patients who received the Targon FN system and the 100 patients in the control group received parallel cannulated screws.
Baseline characteristics were similar in both groups; the average age of participants was 83 years. Women comprised 72% of the Targon group and 75% of the control group.
Investigators used a primary endpoint of revision within 1 year and secondary endpoints of mortality, index hospital stay and adverse events.
No differences between groups
According to the results, the odds ratio of revision within 1 year was 0.85 (P=0.748). This was not significant, Griffin said.
The odds ratio for mortality was 1.56, and for length of stay the mean difference was 0.02 days.
“There is no difference in the risk of revision in the control or Targon groups,” Griffin said at the meeting. He noted finding “no difference in the length of stay, [and] no difference in the mortality. The patients experienced similar complications in both groups.”
The researchers are expanding this research to a full trial.
“We are hoping to test an absolute risk reduction of 15% between the parallel cannulated screws and the Targon group,” Griffin said. “Looking at alpha and beta of 5% and 80% [respectively], we need an additional 50 participants, who have been recruited.”
Griffin said he anticipates the final follow-up will occur in October 2012. – by Colleen Owens
References:
Griffin XL, Achten J, Parsonss N, Costa ML. A pilot randomized controlled trial of a novel fixed-angle implant in intracapsular fractures of the proximal femur. Paper #12-1623. Presented at the 13th EFORT Congress 2012. May 23-25. Berlin.
Parker MHJ, Stedtfeld H. Internal fixation of intracapsular hip fractures with a dynamic locking plate: initial experience and results for 83 patients treated with a new implant. Injury. 2010;41:348-351.
For more information:
Xavier L. Griffin, MA, MSc, MRCS, can be reached at Warwick Orthopaedics, Coventry, United Kingdom CV4 7AL; email: x.griffin@warwick.ac.uk.
Disclosure: Griffin has no relevant financial disclosures.