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临床试验/NCT02390856
NCT02390856已完成不适用

Randomized Controlled Trial: Volar Plate vs. Conventus DRS Intramedullary Fixation for Distal Radius Fractures

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Change from Baseline in Complications at 2 weeks

研究概览

简要总结

Open reduction and internal fixation (ORIF) of unstable distal radius fractures is performed using a variety of fixation techniques. The most common method is fixed angle volar plate application. The investigators plan to compare the outcomes of fixed angle volar plating with a novel FDA approved intramedullary fixation device, Conventus DRS.

详细描述

Distal radius fractures are the most common fractures in the upper extremity. While a widely used method of fracture fixation, numerous studies have shown that locked volar plate fixation is associated with soft tissue irritation, flexor and extensor tendon rupture, and screw penetration of the radiocarpal or the distal radioulnar joint (DRUJ). Prominent hardware mandates hardware removal in 5-18% of cases.

Intramedullary fixation has recently received more attention in the literature because of the minimally invasive procedure required for device implantation. Additionally, because intramedullary fixation places the implant within the bone instead of onto it, the lack of implant exposure, as well as decreased soft tissue dissection, carries the potential for decreased inflammation at the surgical site. This prospective randomized case series will evaluate the clinical and functional outcomes of an expandable intramedullary fixation device and compare the complication profile with traditional fixed angle volar locked plating in a single-surgeon case series at a single hospital.

The wide variety of distal radius fractures demand customized treatment, and a number of different surgical treatments methods are available.(1) While percutaneous/external fixation, dorsal plating, fragment specific fixation, and intramedullary rod fixation have been studied, volar locked plate fixation has emerged over the past decade as the most common and versatile method of fracture fixation. Unfortunately, soft tissue and hardware complications continue to plague volar plate fixation, including digital stiffness, loss of forearm rotation, tendinopathy and tendon rupture, nerve injury and compression, hardware irritation, screw prominence, CRPS, and malunion.

Tarallo et al performed a retrospective review of 303 patients who had undergone volar plate fixation and found that implant-related complications had occurred in 5% of the patients (2). Of these, common complications seen were tendon rupture, screw loosening, and penetration into the articular space. While Tarallo et al studied only hardware related complications, other studies have reported complications associated of volar locking plate fixation as high as 22-27% (3,4). The flexor pollicis longus in particular is vulnerable to rupture, as hardware prominence at the watershed line of the distal radius exposes the FPL and other flexor tendons to frictional forces which result in fraying and rupture (5). Prominent pegs or screws dorsally threaten the extensor pollicis longus and neighboring extensor tendons.

Intramedullary fixation has limited data to date, and the current methods are applicable to a relatively narrow subset of radial fracture types. In a case series of three patients, Gunther and Lynch have shown that intramedullary fixation performed with a partially flexible rod that can be locked into rigid position once implanted in the bone resulted in good functional outcomes (6). Patients returned to their daily lives and at one-year post-operatively no adverse effects were reported. A prospective study analyzing the comparative functional outcomes between intramedullary nail versus volar plate fixation similarly found that functional recovery was comparative between the two groups, and that complication rates were slightly lower in the intramedullary fixation cohort (7). The authors of this study however noted the continued potential for screw penetration into the distal radioulnar joint (DRUJ).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Skeletally mature patients (18-80)
  • Unstable AO Type A and C1 fractures
  • Closed injuries, acute (<14 days), displaced, and unstable

排除标准

  • Patients under the age of 18 or over the age of 85 (if included in our analysis, these would likely be outliers in our patient population)
  • Patients with documented complex regional pain syndrome (CRPS) or history of CRPS
  • Patients with suspected or known allergies to titanium or nickel
  • Patients who are non-English speakers
  • Patients with open wound fractures
  • Patients with inflammatory arthritis
  • Patients with positive pregnancy test
  • Additional musculo-skeletal injuries of the upper extremity would represent exclusion criteria (elbow fractures, scaphoid fractures, and contralateral wrist fracture).
  • Previous major wrist injury or surgery (not including Carpal Tunnel, De Quervain's and trigger finger release)
  • Patients with previously diagnosed metabolic bone disease, currently being treated.
  • Non-English speaking patients (validated, translated questionnaires are not available)
  • Patients needing ipsilateral concomitant operations that will have material impact on the study
  • Patients with previous wrist fractures, prior wrist injury, stiffness, degenerative joint disease, or pain
  • Previous minor surgery - for carpal tunnel, de Quervain's, ganglion, etc. - does not constitute exclusion criteria

结局指标

主要结局

Change from Baseline in Complications at 2 weeks

时间窗: 2 weeks

Patients will be followed for up to one year after surgery to assess any complications which may develop. Complications will be defined as: * Stiffness (defined as inability to touch fingertips to distal palmar crease, OR 45 degrees or more loss of supination or pronation \[compared to uninjured wrist\], OR BOTH) * Loss of reduction * Hardware breakage * Hardware removal * Return to OR * Tendinopathy * Tendon rupture * Neuropathy * Superficial infection * Deep infection * Wound dehiscence * Incisional pain * Chronic Regional Pain Syndrome (CRPS) * None

Change from Baseline in Complications at 6 weeks

时间窗: 6 weeks

Patients will be followed for up to one year after surgery to assess any complications which may develop. Complications will be defined as: * Stiffness (defined as inability to touch fingertips to distal palmar crease, OR 45 degrees or more loss of supination or pronation \[compared to uninjured wrist\], OR BOTH) * Loss of reduction * Hardware breakage * Hardware removal * Return to OR * Tendinopathy * Tendon rupture * Neuropathy * Superficial infection * Deep infection * Wound dehiscence * Incisional pain * Chronic Regional Pain Syndrome (CRPS) * None

Change from Baseline in Complications at 3 months

时间窗: 3 months

Patients will be followed for up to one year after surgery to assess any complications which may develop. Complications will be defined as: * Stiffness (defined as inability to touch fingertips to distal palmar crease, OR 45 degrees or more loss of supination or pronation \[compared to uninjured wrist\], OR BOTH) * Loss of reduction * Hardware breakage * Hardware removal * Return to OR * Tendinopathy * Tendon rupture * Neuropathy * Superficial infection * Deep infection * Wound dehiscence * Incisional pain * Chronic Regional Pain Syndrome (CRPS) * None

Change from Baseline in Complications at 1 year

时间窗: 1 year

Patients will be followed for up to one year after surgery to assess any complications which may develop. Complications will be defined as: * Stiffness (defined as inability to touch fingertips to distal palmar crease, OR 45 degrees or more loss of supination or pronation \[compared to uninjured wrist\], OR BOTH) * Loss of reduction * Hardware breakage * Hardware removal * Return to OR * Tendinopathy * Tendon rupture * Neuropathy * Superficial infection * Deep infection * Wound dehiscence * Incisional pain * Chronic Regional Pain Syndrome (CRPS) * None

次要结局

  • Visual Analog Pain (VAS) Score(Up to 1 year)
  • Tourniquet time(Time of Surgery)
  • Articular Step off(Up to 1 year)
  • Articular Gap(Up to 1 year)
  • Volar tilt(Up to 1 year)
  • Radial inclination(Up to 1 year)
  • Ulnar variance(Up to 1 year)
  • Grip Strength(Up to 1 year)
  • Return to Work/Activities (quickDASH questionnaire)(Up to 1 year)
  • Pinch Strength(Up to 1 year)
  • Intraoperative Complications(Time of Surgery)
  • Wrist Range of Motion(Up to 1 year)
  • Patient-Rated Wrist Evaluation (PRWE) questionnaire(Up to 1 year)
  • Operative time(Time of Surgery)
  • Coronal Shift(Up to 1 year)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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