Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity

Browse trials for

• Scoliosis 594
• Congenital Abnormalities 980

Keywords

• Adolescent
• paediatric
• pediatric
• scoliosis
• spine deformity

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

Lead sponsor

K2M, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Study arms

• Active comparator
  treatment group (MESA)

  Patients randomized to the treatment group will receive surgery with the MESA Rail Deformity System.

  Device: MESA Rail Deformity System

• Active comparator
  control group (USS II)

  Patients randomized to the control group will receive surgery with the DePuy Synthes USS II System.

  Device: DePuy Synthes USS II System

Interventions

• DeviceMESA Rail Deformity System

  The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the MESA Rail Deformity System.

  Also known as: MESA Rail, K2M MESA Rail, MESA, K2M MESA

• DeviceDePuy Synthes USS II System

  The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the DePuy Synthes USS II system.

  Also known as: DePuy, DePuy Synthes, Synthes, USS II, Universal Stainless

Primary outcomes

1. Correction and Maintenance of Spinal Deformity (coronal)

   Radiographic analysis of the spinal deformity in the coronal plane at the indicated time periods will be compared to the pre-operative measurements (OVERALL CHANGE from baseline at each timepoint). Later post-operative measurements will be compared to the initial correction values to establish maintenance of surgical correction over time.

   Time frame: Change from pre-operative to 3 months, 12 months and 24 months post-procedure

2. Correction and Maintenance of Spinal Deformity (sagittal)

   Radiographic analysis of the spinal deformity in the sagittal plane at the indicated time periods will be compared to the pre-operative measurements (OVERALL CHANGE from baseline at each timepoint). Later post-operative measurements will be compared to the initial correction values to establish maintenance of surgical correction over time.

   Time frame: Change from pre-operative to 3 months, 12 months and 24 months post-procedure

Secondary outcomes

1. Back and Leg Pain 10cm Visual Analog Scale (VAS)

   The severity of back and leg pain will be evaluated in all study subjects using a 10-cm visual analog scale (VAS). The study will employ a 15% improvement for success. OVERALL CHANGE from baseline will be assessed at each timepoint.

   Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.

2. SRS-22

   Scoliosis and its treatment have a great impact on the quality of life of the affected patients. The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS-22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self-image/appearance (SA), mental health (MH) and satisfaction with treatment (ST). The scores vary from 1 to 5, in which 5 is the best health quality of life of patients. OVERALL CHANGE from baseline will be assessed at each timepoint.

   Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.

3. Estimated Blood Volume Loss/Salvage Return

   The amount of blood loss over the entire length of the surgery as well as salvage return volumes will be captured intraoperatively.

   Time frame: Operative Data - to be collected immediately after case is completed. Estimated blood loss will be noted by the surgical/anesthesia team and this value can then be immediately collected.

4. Length of Hospital Stay

   The length of hospital stay from the date of admission to the date of discharge will be calculated.

   Time frame: At discharge (up to one week post surgery) - Once the subject has been released from the hospital, the length of hospital stay can be calculated using the intake and discharge dates.

5. Return to Work/School

   The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery will be documented. Once the subject has returned to the "baseline" status this question will not be asked.

   Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.

6. Return to Sport/Physical Activity

   The ability to return to sport as performed by the individual patient pre operatively. Time to walking unaided, running, swimming, trampoline, contact sport, normal social interactions with peer group. Once the subject has returned to the "baseline" status this question will not be asked.

   Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.

7. Use of Analgesia Post-Surgery

   The types and dosages of any analgesia taken by the patient post-surgery will be documented. Overall change from baseline (pre-operative medications) will be analyzed at each interval - anticipation is that use of analgesia decreases and/or ends after surgery.

   Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.