RecruitingACTRN12621000037808

The Plate or Screw in Proximal Phalangeal Fractures [POSI-P1]

A randomised controlled trial assessing total active motion in dorsal plating, lateral plating and intramedullary screws for displaced extra-articular proximal phalangeal fractures: the POSI-P1 Trial.

Sponsor

Royal North Shore Hospital

Enrollment

210 participants

Start Date

Jun 17, 2021

Study Type

Interventional

Conditions

Proximal phalangeal fractures

Summary

The proximal phalanges are the first bone in each finger. When people break their proximal phalanges, the break may need to be fixed surgically. The break may be fixed with a plate on the back of the bone [where the overlying tendon is cut and later repaired]; a plate on the side of the bone; or a screw through the middle of the bone. We want to find out which option gives the best result, in terms of finger movement and overall. The main finding of this study will tell us which surgical option gives the most finger movement, which may allow better use of that finger and hand. The other findings will look at which surgical option gives the best overall result from a patient’s point of view; which option allows the patient to regain better pinching and gripping power; and which option has more frequent risks. This knowledge, and identification of the balance of risks and benefits for each option, will help more patients receive the treatment that will give them the best chance of obtaining good function in that finger and hand, as well as help surgeons guide patients in making informed health decisions. Regaining function will be important not only for the patient [who will be able to return to work or their daily activities more rapidly], but also the health system and community as a whole. Although a plate on the back of the bone has been commonly used to fix breaks, there are concerns that cutting the tendon and putting a plate underneath will cause scarring, diminishing finger motion and patient satisfaction. This study will compare a plate on the back of the proximal phalanx to two other options: a plate on the side of the bone and a screw through the middle of the bone. There are no studies that have previously performed such a comparison. The objective of this study is to determine which of the three options provides the best balance of risk and benefit for the patient. The main finding assessed will be finger movement, which may allow better use of that finger and hand. Other findings will look at the overall result for the patient; pinching and gripping power; and the risks of each operation.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Breaking a finger bone — specifically the first bone in the finger, called the proximal phalanx — sometimes requires surgery to hold the bone in place while it heals. Surgeons have three main options: a plate attached to the back of the bone (the most common approach), a plate on the side of the bone, or a screw inserted through the centre of the bone. Each technique has different trade-offs in terms of finger movement, scarring, and complications, but no study has directly compared all three. This trial at Royal North Shore Hospital is comparing these three surgical approaches in adults who have broken a proximal phalanx. The main outcome being measured is how much movement the affected finger regains after surgery and rehabilitation. Secondary outcomes include grip strength, patient-reported satisfaction, and complication rates. Adults aged 18 or older who have a displaced finger fracture requiring surgery, presented within 14 days of the injury, and are otherwise healthy enough for an operation may be eligible. People with fractures caused by underlying disease, open wounds, or tendon damage at the injury site are excluded. After surgery, all participants will undergo standard hand rehabilitation.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The exposure will be extra-articular proximal phalangeal fractures in adult patients [>18 years old], assessing extensor tendon splitting dorsal plating, extensor tendon sparing lateral plating and extensor tendon sparing intra-medullary screw fixation. In terms of the interventions administered: 1. Lateral plating involves a skin incision, and subluxation of the tendon to visualise the fracture. The plate is placed on the side of the bone [lateral position] and appropriate screws are used to fix the fracture, before the skin is closed. The operation will take roughly an hour, and will be performed by either qualified surgeons, or registrars under the guidance of surgeons 2. Intramedullary screw fixation involves a small percutaneous skin incision, before a guide wire is passed either antegrade [through the base of the proximal phalanx] or retrograde [through the end of the proximal phalanx] past the fracture. The fracture is reduced into an appropriate position, and a cannulated screw is inserted over the wire into the medullary canal of the phalanx to secure the fracture. The percutaneous skin incision is then closed. The operation will take roughly an hour, and will be performed by either qualified surgeons, or registrars under the guidance of surgeons

Locations(8)

Royal North Shore Hospital - St Leonards

NSW,QLD, Australia

Hornsby Ku-ring-gai Hospital - Hornsby

NSW,QLD, Australia

The Northern Beaches Hospital - Frenchs Forest

NSW,QLD, Australia

Fairfield Hospital - Prairiewood

NSW,QLD, Australia

Sydney Hospital and Sydney Eye Hospital - Sydney

NSW,QLD, Australia

Gold Coast University Hospital - Southport

NSW,QLD, Australia

Robina Hospital - Robina

NSW,QLD, Australia

Varsity Lakes Day Hospital - Varsity Lakes

NSW,QLD, Australia

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ACTRN12621000037808