Splinting for the non‐operative management of developmental dysplasia of the hip (DDH) in children under six months of age

Kerry Dwan; Jamie Kirkham; Robin W Paton; Emma Morley; Ashley W Newton; Daniel C Perry

doi:10.1002/14651858.CD012717.pub2

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Figure 1

PRISMA flow diagram

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Figure 2

Risk of bias plot for RCTs

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Figure 3

ROBINS‐I plot: acetabular index at one year

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Figure 4

ROBINS‐I plot: Need for surgical open reduction

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Analysis 1.1

Comparison 1: Dynamic splinting versus delayed or no splinting, Outcome 1: Acetabular index: angle (RCTs)

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Analysis 1.2

Comparison 1: Dynamic splinting versus delayed or no splinting, Outcome 2: Acetabular index: angle (non RCTs)

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Analysis 1.3

Comparison 1: Dynamic splinting versus delayed or no splinting, Outcome 3: Need for operative intervention

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Analysis 1.4

Comparison 1: Dynamic splinting versus delayed or no splinting, Outcome 4: Avascular necrosis

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Analysis 2.1

Comparison 2: Static splinting versus delayed or no splinting, Outcome 1: Acetabular index: angle ≥ 28° (non‐RCTs)

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Analysis 2.2

Comparison 2: Static splinting versus delayed or no splinting, Outcome 2: Need for operative intervention (non‐RCTs)

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Analysis 3.1

Comparison 3: Dynamic splinting versus static splinting, Outcome 1: Acetabular index: angle ≥ 28° (non RCTs)

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Analysis 3.2

Comparison 3: Dynamic splinting versus static splinting, Outcome 2: Acetabular index:angle (non‐RCTs)

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Analysis 3.3

Comparison 3: Dynamic splinting versus static splinting, Outcome 3: Need for operative intervention (non RCTs)

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Analysis 4.1

Comparison 4: Staged weaning versus immediate removal (post hoc comparison), Outcome 1: Acetabular index: angle (non‐RCT)

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Analysis 4.2

Comparison 4: Staged weaning versus immediate removal (post hoc comparison), Outcome 2: Need for operative intervention to achieve reduction (non‐RCTs)

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Analysis 4.3

Comparison 4: Staged weaning versus immediate removal (post hoc comparison), Outcome 3: Need for operative intervention to address dysplasia (non‐RCTs)

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Analysis 4.4

Comparison 4: Staged weaning versus immediate removal (post hoc comparison), Outcome 4: Avascular necrosis (non‐RCTs)

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Summary of findings 1. Dynamic splinting versus delayed or no splinting for the non‐operative management of developmental dysplasia of the hip in babies under six months of age

Outcomes	№ of babies (Studies) Follow up	Certainty of the evidence (GRADE)	Impact
Dynamic splinting versus delayed or no splinting for the non‐operative management of developmental dysplasia of the hip in babies under six months of age
Patient or population: babies under six months of age with all severities of DDH Setting: hospital Intervention: dynamic splinting Comparison: delayed or no splinting
Measurement of acetabular index at 1 year Assessed with: radiographs (angle)	265 (2 RCTs)	⊕⊝⊝⊝ Very low^a,b	One study (stable hips) presented data at one year (MD 0.10, 95% CI −0.74 to 0.94), accounting for correlated observations from hips from the same baby. Another study (stable hips) reported an MD 0.20 (95% CI −1.65 to 2.05) but did not take into account hips from the same baby in the case of bilateral hip dysplasia, so the data were not combined.
Measurement of acetabular index at 2 years Assessed with: radiographs (angle)	181 (2 RCTs)	⊕⊝⊝⊝ Very low^a,b	One study (stable hips) reported a MD −1.90(95% CI −4.76 to 0.96). Another study (stable hips) reported an MD ‐0.10 (95% CI −1.93 to 1.73) but did not take into account hips from the same baby in the case of bilateral hip dysplasia, so the data were not combined.
Measurement of acetabular index at 5 years Assessed with: radiographs (angle)	0 (0 RCTs)	‐	No studies reported data at this time point.
Need for operative intervention at study follow up (range 12 weeks to 1 year)	434 (4 RCTs)	⊕⊝⊝⊝ Very low^a,b	Three studies reported no surgical intervention. In a further study, two babies developed instability in the Pavlik harness group and were subsequently treated with closed reduction and spica cast. It is not explicitly stated if this was to achieve concentric reduction or address residual dysplasia.
Complications: avascular necrosis and femoral nerve palsy at study follow up (range 12 weeks to one year) Assessed with: grading systems (not stated)	390 (3 RCTs)	⊕⊝⊝⊝ Very low^a,b	One study found that "over the period of follow‐up, no complications of treatment were observed, and none of the children developed abnormal clinical findings on hip examination." One study reported no avascular necrosis in either group and another study reported no femoral nerve palsy in either group.
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; DDH: developmental dysplasia of the hip; MD: mean difference; RCT: randomized controlled trial
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect
^aWe downgraded the certainty of the evidence by one level for risk of bias, as studies were at high or unclear risk of bias for selective reporting, sequence generation, allocation concealment and blinding due to limited details reported in the trial reports, and high risk of bias due to incomplete outcome data. ^bWe downgraded the certainty of the evidence by two levels for imprecision, due to the small number of included studies and babies

Summary of findings 1. Dynamic splinting versus delayed or no splinting for the non‐operative management of developmental dysplasia of the hip in babies under six months of age

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Summary of findings 2. Dynamic splinting versus static splinting for the non‐operative management of developmental dysplasia of the hip in babies under six months of age

Outcomes	№ of babies (studies)	Certainty of the evidence (GRADE)	Impact
Dynamic splinting versus static splinting for the non‐operative management of developmental dysplasia of the hip in babies under six months of age
Patient or population: babies under six months of age with stable and unstable hips Setting: hospitals Intervention: dynamic splinting Comparison: static splinting
Measurement of acetabular index at 1 year Assessed with: radiographs (angle)	0 (0 RCTs)	‐	No data presented and it is unclear if the outcome was measured.
Measurement of acetabular index at 2 years Assessed with: radiographs (angle)	0 (0 RCTs)	‐	No data presented and it is unclear if the outcome was measured.
Measurement of acetabular index at 5 years Assessed with: radiographs (angle)	0 (0 RCTs)	‐	No data presented and it is unclear if the outcome was measured.
Need for operative intervention	0 (0 RCTs)	‐	No data presented and it is unclear if the outcome was measured.
Complications: avascular necrosis at 4 months Assessed with: grading systems (not stated)	118 hips (1 RCT)	⊕⊝⊝⊝ Very low^a,b	One RCT reported no occurrence of avascular necrosis in either group.
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; DDH: developmental dysplasia of the hip; RCT: randomized controlled trial
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect
^aWe downgraded the certainty of the evidence by one level for risk of bias, as we judged risk of bias as generally unclear in all domains except incomplete outcome data, due to limited details reported in the trial report. ^bWe downgraded the certainty of the evidence by two levels for imprecision, due to there only being one small study.

Summary of findings 2. Dynamic splinting versus static splinting for the non‐operative management of developmental dysplasia of the hip in babies under six months of age

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Table 1. ORBIT matrix

Study	Measurement of acetabular index	Need for operative intervention	Avascular necrosis	Femoral nerve palsy/other nerve palsies	Pressure areas on skin	Health economic assessment	Bonding between parents and child	Motor skill development	Other outcomes
Azzoni 2011	x	Reported	Reported	x	x	x	x	x	Time to recovery
Bergo 2013	x	x	x	x	x	x	x	x	Psychosocial outcomes, anxiety
Bram 2021	Reported	x	x	x	x	x	x	x	Time spent in harness
Gardiner 1990	x	Reported	Reported	x	x	x	x	x	Abnormal hips
Gou 2021	Reported	x	x	x	x	x	x	x	Success/ failure
Kim 2019	Reported	Reported	x	x	x	x	x	x	None
Laborie 2014	Measured	Reported	Reported	x	x	x	x	x	None
Larson 2019	x	Reported	x	x	x	x	Reported	x	Success/failure
Lee 2022	x	x	x	x	x	x	x	x	Alpha angle at 1 month, rate of improvement to Graf type I hips in 1 month, any problems or morbidities in the study period, and number of ultrasound examinations and orthopaedic clinic visits in the first year
Lyu 2021	Reported	x	Reported	Reported	x	x	x	x	Time needed to achieve Graf type IIb
Munkhuu 2013	x	x	x	x	x	x	x	x	Development of hips, complications
Murphy 2017	x	Partially reported	x	x	x	x	x	x	Resolution of dysplasia on subsequent imaging and failure of resolution or deterioration on subsequent imaging
Paton 2004	x	Reported	Reported	x	x	x	x	x	Late splintage
Pollett 2020	Reported	Reported	x	Reported	x	x	x	x	Bony roof angle, modifed tonnis classification
Ran 2020	Reported	Reported	Reported	Reported	x	x	x	x	Failure/ success, center‐edge angle
Reikerås 2002	Reported	x	x	x	x	x	x	x	Provokable instability, beta angles
Rosendahl 2010	Reported	NA	Reported	Reported	Reported	x	x	x	None
Sucato 1999	Reported	x	x	x	x	x	x	x	None
Upasani 2016	Partially reported	Reported	Reported	Reported	x	x	x	x	Osteonecrosis
Westacott 2014	Reported	Reported	Rreported	x	x	x	x	x	Retreatment, other complications, successful treatment
Wilkinson 2002	x	Reported	Reported	x	x	x	x	x	Number with acetabular angle ≥ 28°; improvement on ultrasound; further treatment with an abduction plaster; deformaties
Wood 2000	Reported	Reported	x	x	x	x	x	x	Acetabular cover

Table 1. ORBIT matrix

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Table 2. ROBINS‐I

Bias domain	Bias due to confounding	Bias in selection of participants into the study	Bias in the classification of interventions	Bias due to departures from intended interventions	Bias due to missing data	Bias in measurement of outcomes	Bias in selection of the reported result	Overall
*Acetabular index at one year*
Bram 2021	Serious	Moderate	Low	Moderate	Serious	Moderate	Moderate	Serious
Kim 2019	Moderate	No information	Low	Moderate	Moderate	Low	Moderate	Moderate
Murphy 2017	No information	Low	Low	No information	No information	Moderate	Moderate	Moderate
Paton 2004	Serious	Moderate	Low	Moderate	Moderate	Serious	Moderate	Serious
Sucato 1999	Low	Serious	Low	Moderate	Moderate	Moderate	Moderate	Serious
Upasani 2016	Low	Low	Low	Moderate	Moderate	Moderate	Moderate	Moderate
Wilkinson 2002	Serious	Moderate	Serious	No information	Moderate	Serious	Moderate	Serious
*Need for surgical open reduction*
Kim 2019	Moderate	No information	Low	Moderate	Moderate	Low	Moderate	Moderate
Laborie 2014	Critical	Low	Moderate	Low	Moderate	Moderate	Moderate	Critical
Larson 2019	Serious	Serious	Low	Moderate	Moderate	Moderate	Moderate	Serious
Murphy 2017	No information	Low	Low	No information	No information	Moderate	Moderate	Moderate
Paton 2004	Serious	Moderate	Low	Moderate	Moderate	Serious	Moderate	Serious
Ran 2020	Serious	Serious	Serious	Low	Serious	Low	Low	Serious
Upasani 2016	Low	Low	Low	Moderate	Moderate	Moderate	Moderate	Moderate
Wilkinson 2002	Serious	Moderate	Serious	No information	Moderate	Serious	Moderate	Serious

Table 2. ROBINS‐I

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Table 3. Dynamic splinting versus delayed or none

Study	Design	Intervention	Comparator
Bergo 2013	Cross‐sectional study	Early splinting (Frejka pillow)	Late splinting
Gardiner 1990	Quasi‐RCT	Immediate splinting Sonographic surveillance for 2 weeks	Control
Kim 2019	Prospective	Pavlik	Observed
Laborie 2014	Observational	Abduction splint (Frejka splint): persistent dislocated or dislocatable	Watchful waiting: clinically or ultrasound unstable but not dislocatable hips
Larson 2019	Reterospective	Pavlik harness	Groups were divided based on the age at which the Pavlik harness was initiated: group 1 = < 30 days; group 2 = 30 to 60 days; group 3 = > 60 days
Murphy 2017	Reterospective	Pavlik harness	Followed up without treatment
Paton 2004	Prospective	Early splinting (Pavlik)	Follow up with ultrasound
Pollett 2020	RCT	Pavlik harness	Active surveillance
Reikerås 2002	Babies 'divided' into 2 groups	Frejkas pillow for 16 weeks	Untreated
Rosendahl 2010	RCT	Immediate abduction splinting for at least 6 weeks (Frejka pillow splint with sonographic follow up)	Active sonographic surveillance but no treatment for 6 weeks
Sucato 1999	Reterospective review (observational)	Pavlik (chosen at the discretion of the treating physician)	No treatment
Wilkinson 2002	Retrospective	Pavlik	Not splinted
Wood 2000	RCT	Pavlik	No splint
RCT: Randomised controlled trial

Table 3. Dynamic splinting versus delayed or none

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Table 4. Static splinting versus delayed or none

Study	Design	Intervention	Comparator
Munkhuu 2013	Prospective cohort	Type 2c‐4: Tubingen hip flexion splint	Type 2a: ultrasound follow‐up
Wilkinson 2002	Retrospective	Craig; Von Rosen	Not splinted

Table 4. Static splinting versus delayed or none

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Table 5. Dynamic versus static splinting

Study	Design	Intervention	Comparator
Azzoni 2011	RCT	Static: Teuffel Mignon	Dynamic: Coxa‐flex
Gou 2021	Retrospective cohort	Static: Human Brace	Dynamic: Pavlik harness
Lyu 2021	Retrospective cohort	Static: Tubigen	Dynamic: Pavlik harness
Ran 2020	Retrospective cohort	Static: Tubigen	Dynamic: Pavlik harness
Upasani 2016	Prospective cohort	Static: brace treatment (Denis Browne, Von Rosen, Plastazote)	Dynamic: Pavlik harness
Wilkinson 2002	Retrospective cohort	Static: Craig; Von Rosen	Dynamic: Pavlik harness
RCT: randomised controlled trial

Table 5. Dynamic versus static splinting

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Comparison 1. Dynamic splinting versus delayed or no splinting

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Acetabular index: angle (RCTs) Show forest plot	4		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.1.1 Six months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.1.2 One year	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.1.3 Two years	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.2 Acetabular index: angle (non RCTs) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

1.2.1 Two years	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
1.3 Need for operative intervention Show forest plot	6		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.3.1 RCT	3		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.3.2 Prospective study	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.3.3 Retrospective study	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.4 Avascular necrosis Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.4.1 Quasi RCT	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.4.2 Prospective study	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.4.3 Retrospective study	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.4.4 Observational study	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 1. Dynamic splinting versus delayed or no splinting

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Comparison 2. Static splinting versus delayed or no splinting

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Acetabular index: angle ≥ 28° (non‐RCTs) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.2 Need for operative intervention (non‐RCTs) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 2. Static splinting versus delayed or no splinting

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Comparison 3. Dynamic splinting versus static splinting

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Acetabular index: angle ≥ 28° (non RCTs) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.2 Acetabular index:angle (non‐RCTs) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.2.1 Less than 6 months	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3.2.2 2 years	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
3.3 Need for operative intervention (non RCTs) Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.3.1 Prospective cohort	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.3.2 Retrospective study	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 3. Dynamic splinting versus static splinting

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Comparison 4. Staged weaning versus immediate removal (post hoc comparison)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Acetabular index: angle (non‐RCT) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.1.1 Hips with positive Ortolani sign	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.1.2 Stable Hips	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
4.2 Need for operative intervention to achieve reduction (non‐RCTs) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.3 Need for operative intervention to address dysplasia (non‐RCTs) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.4 Avascular necrosis (non‐RCTs) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 4. Staged weaning versus immediate removal (post hoc comparison)

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