Adhesion barrier use after osteosynthesis not supported in proximal phalangeal fractures

Study Type: Therapy
OE Level of Evidence: 1
Journal Level of Evidence: N/A
Synopsis
42 patients were randomized to undergo open reduction and internal fixation for a proximal phalangeal fracture either with or without the placement of a denaturated oxidized cellulose adhesion barrier. The purpose of this study was to determine if an adhesion barrier resulted in significantly different total angular movement, DASH scores, requirement of secondary surgery, and adverse events) when compared to treatment without the use of an adhesion barrier after 6 months. Results demonstrated that Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Non-Industry funded
Sponsor: Department of Hand, Plastic and Reconstructive Surgery, Cantonal Hospital St Gallen, Switzerland
Conflicts: None disclosed
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Why was this study needed now?
Reduction in range of motion following surgical treatment of finer proximal phalangeal fractures is most commonly attributed to adhesion formation. Therefore, it has been proposed that the use of an adhesion barrier between bone (and plate) and soft tissue may remedy this complication. However, the proposed materials thus far such as cellophane, aminoplastin, hyaluronic acid gel, and alginate have revealed unsatisfactory results. The newly proposed adhesion barrier made of denaturated oxidized cellulose has garnered interest due to its bio-dissolvable properties. Thus, the aim of this study was to determine the efficacy of denaturated oxidized cellulose adhesion barrier in terms of total angular movement and other various patient-focused outcomes.
What was the principal research question?
For patients undergoing surgical treatment for proximal phalangeal fracture, did the placement of a denaturated oxidized cellulose adhesion barrier result in significantly different total angular movement (TAM) of the affected finger when compared to no adhesion barrier, assessed up to six months postoperatively?
Population: 42 patients, older than 18 years of age, with single-closed fracture of a proximal phalanx of a finger and deemed unsuitable for conservative treatment. All patients underwent open reduction and plate and screw fixation under regional anaesthesia via a dorsal approach, and received customized splint and occupational therapy.
Intervention: Adhesion Barrier group: a denaturated oxidized cellulose adhesion barrier was placed between the plate and screws and the extensor tendon of the affected finger (n=21, 18 completed follow-up).
Comparison: Control group: no adhesion barrier was placed in treatment of the fractured finger (n=21, 19 completed follow-up).
Outcomes: The primary outcome of interest was the total angular movement (TAM) of the finger with a manual goniometer when compared the same finger on the opposite hand. Secondary outcomes of interest included the disability of the arm, shoulder and hand (DASH) scores, the ability to work after certain follow-up points, requirement of secondary surgery (tenolysis), and incidence of postoperative complication.
Methods: RCT: prospective, double-blinded
Time: Outcomes of interest were evaluated at baseline and at 2 weeks, 6 weeks, 3 months, and 6 months postoperatively.
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.