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Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis

ConditionsDegenerative Lumbar DiseaseScoliosisDegenerative Scoliosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorXuanwu Hospital, Beijing

About this trial

Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with degenerative lumbar scoliosis (DLS) who underwent correction surgery with reference to our priority-matching correction technique and the standard reported by Obeid and colleagues. Our findings may provide tangible guidance for surgical decision-making in DLS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A diagnosis of DLS based on radiography and previous medical record,

Age > 50 years

Disqualifiers

Leg length discrepancy,

A history of spinal or pelvic surgery,

A history of neuromuscular diseases, arthritis or tumor.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Priority-matching correction technique in DLS

    Procedure/Surgery

    For Type 1 global coronal malalignment (GCM), TL/L curve makes the primary contri- bution on C7PL shifting. First, inserting pedicle screws bilaterally. Second, aggressively decreasing the magnitude of TL/L curve. Third, moderately leveling L4 endplate to pull the fusion segments to the middle line with hand pressure on the convexity of TL/L curve. If the correctability of the key curve was limited, the correction of the minor curve would be con- vergent. For Type 2 GCM, LS curve makes the primary contribution on C7PL shifting. First, releasing LS curve from the concave side using facetectomy after screws inserted. Second, performing L4-5 or L5-S1 trans- foraminal lumbar interbody fusion (TLIF) from the con- vexity of the fractional curve, with cages inserted at the concave side to assist deformity correction. Third, compressing the convexity of LS to horizontalize L4 endplate, followed by moderate manipulative reduction of TL/L curve to adjust intraoperative coronal balance.

  • Traditional correction technique in DLS

    Procedure/Surgery

    In concave coronal malalignment (CM), the correction of the main curve improves the CM, thus we can talk about convergent corrective objectives. The ability to correct the CM depends on the correctability of the main curve. The need of three-column osteotomies in order to obtain correction of CM depends on the location and flexibility of the main curve. The correction of convex CM depends on the correction of the lumbosacral curve. The correction strategy will depend on many factors including the driver of the deformity, which should always be fused, but also the degeneration and stiffness of the compensatory curve which can lead to more extended fusion. The need of three-column osteotomies depends mainly on the stiffness of the lumbosacral curve.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: DLS patients undergoing correction surgery in reference to our novel criteriaExperimental treatment 1 intervention
Group B: DLS patients undergoing correction surgery in reference to Obeid classificationOther 1 intervention

Trial outcomes

Primary outcomes

1

Scoliosis Research Society-22

The 22-item SRS-22r questionnaire is specific to scoliosis-related patient-reported outcomes, and consists of 6 domains: function, pain, self-image, mental health, satisfaction, and subtotal, with each domain being scored from 1 to 5 where higher scores correspond to better patient outcomes.

Time frame
One month, 3 months, 6 months, 1 year, and 2 years after surgery
2

Oswestry disability index

The validated ODI is a self-administered questionnaire for evaluating back-specific functional disability, consisting of 10 items with scores from 0 to 5, and higher ODI indicates more severe disability.

Time frame
One month, 3 months, 6 months, 1 year, and 2 years after surgery
3

Achievement of minimal clinically important difference

A prespecified MCID of 10 points was used for the ODI. The minimum clinically important difference (MCID) values for the SRS-22r based on data from a Japanese cohort have previously been reported as follows: function = 0.90, pain = 0.85, self-image = 1.05, mental health = 0.70, and subtotal = 1.05.

Time frame
Two years after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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Xuanwu Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

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