|Methods||Method of randomisation: randomised. |
Assessor blinding: yes.
Loss to follow-up at 2 years: 0/45.
Patients' consent to randomisation: yes.
Number of surgeons: same surgeon performed the radial head replacement operations, but no information on who performed ORIF.
|Participants||Study location: Changhai Hospital, Shanghai, China.|
Study period: January 2004 to January 2009.
Study participants: 45 participants with unstable, multi-fragmented fractures of the radial head.
Age range: mean age 37 years, range 19 to 68 years.
Gender: 11 women and 34 men.
1. Mason III type radial head fracture
2. Including multiple injuries: collateral ulnar ligament injury, ulnar coronoid process fracture, ulnar anconeal process or ulnar proximal end fracture, interosseous ligament injury or/and posterior cubital articulation dislocation
1. Mason I, II type radial head fracture
2. Severely comminuted radial head fracture
3. Old radial head fracture
4. Children with radial head fracture
5. Psychological and/social conditions with poor compliance
|Interventions||Interventions started: within a mean of 4.9 days after injury |
1. Radial head replacement
Using a monopolar titanium radial head prostheses matched to each individual from Wright Medical Technology.
Using the AO mini steel plate interfixed system combined with Kirschner wires.
Radial head replacement: active exercises were started after three to seven days rest in a splint except for cases of additional elbow injuries. If complicating injuries were present, the elbow joints were rested in a 60° flexion position for three weeks followed by rehabilitation exercises, with gradually increased intensity.
ORIF: Postoperatively, for patients with associated injuries, long-arm cast plaster was used to immobilise the elbow at 90°, which was changed to short-arm cast plaster after two weeks. Meanwhile, active rotation of the forearm was allowed. After four weeks, the plaster was removed followed by rehabilitation exercises. For patients without associated injuries, the elbow joints were suspended at 90° for two weeks and active rotational movement of the forearm was undertaken. Two weeks later, active flexion–extension movement was recommended. The whole process was taken with gradually increased intensity.
|Outcomes||Length of follow-up: 2.8 years (range 1 to 5 years)|
Broberg and Morrey functional rating scores (including range of motion, grip strength, functional stability, and pain)
Adverse events (including deep wound infection, range of motion deficit > 30°, no or delayed healing, internal fixation failure, secondary fragment displacement, joint stiffness and heterotopic ossification)
|Notes||Postoperatively, for participants with associated injuries, long-arm cast plaster was used to immobilise the elbow at 90°, which was changed to short-arm cast plaster after two weeks. After four weeks, the plaster was removed followed by rehabilitation exercises. For participants without associated injuries, the elbow joints were suspended at 90° for two weeks and active rotational movement of the forearm was undertaken.|
|Risk of bias|
|Bias||Authors' judgement||Support for judgement|
|Random sequence generation (selection bias)||Unclear risk||All 45 participants were randomly divided into the radial head replacement group (22 cases) and the ORIF group (23 cases). But randomisation method was not described.|
|Allocation concealment (selection bias)||Unclear risk||The method of concealment was not described.|
|Blinding of participants and personnel (performance bias) |
|High risk||Surgeons performing the operations could not be blinded.|
|Blinding of outcome assessment (detection bias) |
|Unclear risk||The author wrote that "all of the reviewers were blinded to evaluate postoperative functions by means of a randomised block design", but no information to show the success of this unusual process.|
|Incomplete outcome data (attrition bias) |
|Low risk||No participant was lost and outcome data were complete.|
|Selective reporting (reporting bias)||Unclear risk||The study protocol was not found and it was unclear if the published report included all planned outcomes.|
|Other bias||Unclear risk||The authors declared they had no conflicts of interest.|
Separate baseline characteristics were not provided for the two groups.
No details stated of the surgeons conducting ORIF, but these seemed to experienced.