Intervention Review

You have free access to this content

Surgical interventions for treating radial head fractures in adults

  1. Yu Gao1,
  2. Wei Zhang2,
  3. Xin Duan3,
  4. Jing Yang4,
  5. Mohammed Al-Qwbani4,
  6. Jingtong Lv4,
  7. Zhou Xiang1,*

Editorial Group: Cochrane Bone, Joint and Muscle Trauma Group

Published Online: 31 MAY 2013

Assessed as up-to-date: 14 AUG 2012

DOI: 10.1002/14651858.CD008987.pub2


How to Cite

Gao Y, Zhang W, Duan X, Yang J, Al-Qwbani M, Lv J, Xiang Z. Surgical interventions for treating radial head fractures in adults. Cochrane Database of Systematic Reviews 2013, Issue 5. Art. No.: CD008987. DOI: 10.1002/14651858.CD008987.pub2.

Author Information

  1. 1

    West China Hospital, Sichuan University, Department of Orthopedics, State Key Laboratory of Biotherapy, Chengdu, Sichuan, China

  2. 2

    The General Hospital of the People's Liberation Army (PLAGH), Department of Orthopaedic Surgery, Beijing, Beijing, China

  3. 3

    The Second People's Hospital of Chengdu, Department of Orthopaedics, Chengdu, Sichuan, China

  4. 4

    West China Hospital, Sichuan University, Department of Orthopaedic Surgery, Chengdu, Sichuan, China

*Zhou Xiang, Department of Orthopedics, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, No.37, Guo Xue Xiang, Chengdu, Sichuan, 610041, China. Xiangzhou15@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 31 MAY 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Chen 2011

MethodsMethod 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.


ParticipantsStudy 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.

Inclusion criteria:

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

Exclusion criteria:

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


InterventionsInterventions 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.
2. ORIF

Using the AO mini steel plate interfixed system combined with Kirschner wires.
Postoperative rehabilitation:

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.

Assigned: 22/23
Completed: 22/23


OutcomesLength 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)


NotesPostoperatively, 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

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskAll 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 riskThe method of concealment was not described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskSurgeons performing the operations could not be blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe 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)
All outcomes
Low riskNo participant was lost and outcome data were complete.

Selective reporting (reporting bias)Unclear riskThe study protocol was not found and it was unclear if the published report included all planned outcomes.

Other biasUnclear riskThe 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.

Helling 2006

MethodsMethod of randomisation: randomised by telephone by an independent agency.
Assessor blinding: unknown.
Loss to follow-up at 2 years: 29/164 (29 loss of follow-up).

Patients' consent to randomisation: yes.

Number of surgeons: unknown.


ParticipantsStudy location: 24 centres, Germany.

Study period: April 1993 to September 1997.

Study participants: 184 participants were treated. Nineteen were excluded because of radial head resection in 9 participants, use of biodegradable implants other than the study material in 3, radial head prosthesis implantation in 1, non-operative treatment in 1, and unreliable available data (i.e., the documented data were contradictory or completely missing) in 5 participants, all of whom stemmed from 1 centre. Initial pre-operative data were collected from 165 participants but 1 patient's notes were lost. Two-year follow-up data were available for 135 patients.

Age: mean age 39 years, range 16 to 71 years.

Gender: 59 women, 106 men.

Inclusion criteria:

1. Isolated fracture of the radial head

2. AO-classification 21 B2 (any subgroup)

3. Fragment displacement > 1.0 mm or > 10°

4. Informed consent, written or oral in the presence of a witness

Exclusion criteria:

1. AO-classification type "A", radial neck

2. AO-classification type "C", additional olecranon

3. Immature skeleton

4. Implants in place from previous intervention

5. Severe chronic and/or terminal diseases

6. Psychological and/or social conditions preventing rehabilitation

7. Missing informed consent

8. Advanced osteoporosis preventing surgical treatment of fractures


InterventionsInterventions started: within a mean of 5.8 days after injury
1. Biodegradable polylactide pins

Participants were fixed with 2.0-mm-diameter polylactide pins with an original length of 35 mm. The polylactide used was a copolymer of co-L/DL-lactide in a 70:30 ratio. At least 1 or 2 polylactide pins were inserted horizontally. The head of each pin was countersunk below the surface of the surrounding cartilage.
2. Standard mini-fragment metal screws

Participants were treated with countersunk metal lag screws (diameters 1.5 mm to 2.0 mm) from the AO mini-fragment set.

Postoperative treatment consisted of physiotherapy for up to 6 weeks. In both groups, a temporary dorsal elbow splint at 60° flexion was applied to an equal number of participants (22 in each group) for a maximum of 3 weeks.

Postoperative rehabilitation: all patients in both groups underwent the same postoperative treatment.

Assigned: no described
Completed: 83/82


OutcomesLength of follow-up: 2 years (average, 25 months; range 20 to 35 months), also 6 weeks and 1 year (average, 12 months; range, 7 to 19 months)

Broberg and Morrey functional rating scores (including range of motion, grip strength, functional stability, and pain)

Adverse events, including deep wound infection, foreign-body reactions of the soft tissues grade 2 to 4 (seroma, spontaneous discharge, bacterial superinfection), range of motion deficit of more than 30° on 1 axis, fragment displacement of more than 1 mm compared with postoperative results, reoperation for any reason other than hardware removal, osteolysis grade 4 at the implant site preventing or delaying fracture healing, or a combination of these.


NotesIn standard mini-fragment metal implants group, additional mini-fragment plates or Kirschner (K) wires could be used, if deemed necessary.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe participants were randomised by telephone by an independent agency.

Allocation concealment (selection bias)Low riskThe participants were randomised by telephone by an independent agency.

Blinding of participants and personnel (performance bias)
All outcomes
High riskThe surgeons conducting the surgery would not have been blinded.

Blinding of outcome assessment (detection bias)
All outcomes
High riskIt was not described if the outcome assessments were blinded.

Incomplete outcome data (attrition bias)
All outcomes
High riskOf 184 enrolled in the trial, 19 people were excluded after randomisation. There was an imbalance between the two groups in the number of participants lost at 2-year follow-up.

Selective reporting (reporting bias)Unclear riskThe study protocol was not found and it was unclear if the published report included all planned outcomes.

Other biasUnclear riskConflicts of interest and surgeon's expertise with the interventions were not described. Baseline data, provided 165 participants, showed some comparability between the two groups.

Rehabilitation was the same for both groups.

Ruan 2009

MethodsMethod of randomisation: randomised
Assessor blinding: yes
Loss to follow-up at 2 years: 0/22

Patients’ consent to randomisation: yes.

Number of surgeons: not known.


ParticipantsStudy location: Shanghai 6th People's Hospital, Shanghai, China.

Study period: April 2002 and February 2006.

Study participants: 22 participants of Mason type III.

Age range: the average age was 37.4 years in the replacement group and 40.1 years in the ORIF group.

Gender: 9 women and 13 men.

Inclusion criteria: radial head fractures of Mason type III.

Exclusion criteria: not described.


InterventionsInterventions started: In the replacement group, 12 participants had fresh fractures and two participants had old fractures. In ORIF group, all eight participants had fresh fractures. All participants who had fresh fractures were treated within 4 to 17 days after injury, and the two old fracture cases were treated after 12 and 18 months of injury.
1. radial head replacement

Using radial head prosthesis of Tornier Inc in France.

2. ORIF

With cannulated screws and K wires. And all eight participants were immobilised in plaster for four weeks. Rehabilitation began when plasters were removed four weeks after surgery.
Postoperative rehabilitation: same in both the groups.

Assigned: 14/8
Completed: 14/8


OutcomesLength of follow-up: The 14 participants who had received radial head replacement were followed up for an average of 15.9 months (range 10 to 27 months). Mean follow-up of the eight cases in the ORIF group was 14 months (range 10 to 21 months).

Broberg and Morrey functional rating scores.

Adverse events (including heterotopic ossification, bone nonunion and bone absorption).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskTwenty-two participants were randomly divided into the radial head replacement group (14 cases) and the ORIF group (8 cases). But randomisation method was not described.

Allocation concealment (selection bias)Unclear riskThe method of concealment was not described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskThe surgeons conducting the surgery would not have been blinded.

Blinding of outcome assessment (detection bias)
All outcomes
High riskIt was not described if the outcome assessments were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo participant was lost and outcome data were complete.

Selective reporting (reporting bias)Unclear riskThe study protocol was not found and it was unclear if the published report included all expected outcomes.

Other biasHigh riskConflicts of interest and surgeon's expertise in ORIF were not described. For this small trial, the inclusion of 2 old fractures in the replacement group is of concern in terms of selection bias.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Erturer 2010This was not a randomised or quasi-randomised controlled trial.

Frankle 1999Retrospective study. Patients were treated by conservative or surgical treatment.

Ikeda 2005This was not a randomised or quasi-randomised controlled trial.

Liu 2010This was not a randomised or quasi-randomised controlled trial.

Obert 2005Retrospective comparative study.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Dabby 2006

MethodsControlled trial

Participants20 patients

InterventionsOpen reduction and internal fixation (10 patients) versus Corin Radial head prosthesis (10 patients).

OutcomesROM, muscle strength, elbow stability, function ability, pain

NotesAbstract report only. Efforts continue to obtain a full report of this trial.

 
Characteristics of ongoing studies [ordered by study ID]
Ascension 2009

Trial name or titleSafety and effectiveness study of Ascension's pyrocarbon radial head compared to Ascension's metal radial head

MethodsA randomised, double blind clinical trial

ParticipantsPatients must need a radial head replacement for:

  • Degenerative, post-traumatic or rheumatoid arthritis
  • Primary replacement after fracture of the radial head
  • Relief of symptoms after radial head resection
  • Revision of failed radial head arthroplasty
  • Skeletally mature individuals ages 18 - 85

InterventionsCarbon modular radial head versus metal radial head

OutcomesThe proportion of patient successes

Starting dateJanuary 2009

Contact informationXiaosong Yang, MSN 512-836-5001 ext 1536 xyang@ascensionortho.com

NotesClinical Trials.gov Identifier: NCT00825409

 
Comparison 1. Radial head replacement versus ORIF

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Broberg and Morrey functional rating score (0 to 100: best outcome) at 2 years1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Broberg and Morrey functional rating score - excellent or good results267Risk Ratio (M-H, Fixed, 95% CI)1.88 [1.27, 2.77]

 3 Overall adverse events267Risk Ratio (M-H, Fixed, 95% CI)0.33 [0.14, 0.77]

 4 Individual adverse events2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 Range of motion deficit > 30°
145Risk Ratio (M-H, Fixed, 95% CI)0.52 [0.11, 2.57]

    4.2 Stiffness caused by prostheses
145Risk Ratio (M-H, Fixed, 95% CI)3.13 [0.13, 72.99]

    4.3 Secondary fragment displacement
145Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 2.73]

    4.4 Deep wound infection
145Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.01, 8.11]

    4.5 Heterotopic ossification
267Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.21, 5.01]

    4.6 Bone nonunion
145Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.01, 8.11]

    4.7 "Bone nonunion and bone absorption"
122Risk Ratio (M-H, Fixed, 95% CI)0.07 [0.00, 1.10]

 
Comparison 2. Biodegradable pins versus standard metal screws

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Broberg and Morrey functional rating score (0 to 100: best result) at 2 years1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Broberg and Morrey functional rating score - excellent or good results1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Overall adverse events1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 4 Individual adverse events1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Range of motion deficit > 30°
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 Secondary fragment displacement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.3 Re-operation
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.4 Osteolysis grade 4 (disturbance of fracture healing)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.5 Deep wound infection
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]