Clinical Trial: A Randomized Controlled Trial of Leg Length Discrepancy Techniques

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: PEDS Trial: Percutaneous Epiphysiodesis, Drill Versus Screws for Leg Length Discrepancy A Randomized Clinical Trial

Brief Summary: This is a randomized clinical trial of epiphysiodesis techniques: percutaneous transphyseal screw epiphysiodesis versus percutaneous drill epiphysiodesis for the correction of leg length discrepancy. Failed epiphysiodesis was selected as the primary outcome. Failed epiphysiodesis was defined as one or more of the following: development of angular deformity > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected. EOS, low dose biplanar X-Ray, will be used to make all length measurements. Secondary outcomes assess mean growth at the physis following epiphysiodesis, in the subset of patients with bead implantation, fluoroscopy and operative times, length of stay, return to full weight bearing, as well as functional and quality of life outcomes. The following outcome scales will be used to measure pain (VAS), quality of life (PROMIS Pediatric Pain Interference Scale), and function (PROMIS Pediatric Mobility Scale, Pedi-FABS, and UCLA Activity Score). Each of these scales has been validated for use in children (Beyer, Denyes, & Villarruel, 1992; DeWitt et al., 2011; Fabricant et al., 2013; Novais et al., 2014; Varni et al., 2010a). We will also determine the cost associated with each technique and perform a cost-effectiveness analysis to establish which technique is preferred from a societal perspective.

Detailed Summary:

Drill and screw epiphysiodesis are the two most common techniques for surgical correction of predicted limb length discrepancies 2-5cm. Both procedures require minimal incisions, less than 1cm, (Canale & Christian, 1990; Metaizeau et al., 1998). Previous studies have demonstrated that both drill and screw epiphysiodesis result in improved outcomes compared to open techniques (Alzahrani, Behairy, Alhossan, Arab, & Alammari, 2003; Canale & Christian, 1990). Moreover, alternative approaches such as medial and lateral 8 plates may not sufficiently tether growth, or cause peripheral but not central growth arrest (Stewart et al., 2013). We selected drill vs. screw epiphysiodesis as the two treatment groups as they are both minimally invasive, relatively effective, in common usage, and are thought to differ in costs and other characteristics.

Although outcomes of drill and screw epiphysiodesis exist{{10 Campens,C. 2010; 11 Ghanem,I. 2011}} , the assessments are retrospective non-randomized series, which may be at risk for selection bias, and may not adequately capture all of the outcomes of interest, depending on what data is routinely collected and documented in the medical chart. To our knowledge, no prospective randomized comparison of epiphysiodesis techniques and clinical outcomes has been published accurately assessing how effective each technique is in disabling growth at the physis, or taking into account patient-centered outcomes or cost. Operative measures such as the surgical time and radiation exposure from intra-operative fluoroscopy have not previously been compared. Patient-centered outcomes such as level of pain, activity, and function by measures such PROMIS and Ped-FABS, have not been previously assessed in this population. The proposed research study aims to fill this gap.

This study was designed as
Sponsor: Hospital for Special Surgery, New York

Current Primary Outcome: Failure of Epiphysiodesis [ Time Frame: 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months ]

Original Primary Outcome: Mean Growth at Physis after Epiphysiodesis [ Time Frame: 6 months ]

Current Secondary Outcome:

• Change in Physeal Growth [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months ]
  Distance between tantalum beads.
• Time to Baseline Pain [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months ]
  Visual Analog Scale
• Quality of Life [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months ]
  PROMIS Pain Interference and Mobility
• Length of Hospital Stay [ Time Frame: An expected average of 2 days ]
  participants will be followed for the duration of hospital stay (discharge date - admission date)
• Time to full weight-bearing [ Time Frame: 2- 6 weeks ]
  Documenting the number of days until patient could weight-bear without using devices as crutches or wheelchairs.
• Need for Splint or Cast [ Time Frame: 2- 6 weeks ]
  Documenting days worn.
• Days Until Return to Sports [ Time Frame: 2-6 weeks ]
  Documenting how many days elapsed before the patient returned to sports. This information will be recorded in a post-operative pain and function diary. Return to sports is typically surgeon driven, but timing for return to sports is not standardized in clinical practice. In the current study patients will be allowed to return to sports when pain free, no longer limping and strength is equivalent to the non-operative side
• Need for Secondary Surgery [ Time Frame: 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months ]
  Assessed in follow up clinical visits and documented in clinical records
• Physical Activity Level [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months ]
  Pediatric activity scale assessment measured by HSS Pedi-FABS.
• Physical Activity Level [ Time Frame: Baseline, 2-6 weeks, 6 months, 12 months, 24 months, and 60 months ]
  UCLA Activity Scale
• Complications [ Time Frame: 2-6 weeks, 6 months, 12 months, 24 months, and 60 months ]
  Complications will be tracked for two years post surgery. Due to previous research, which is outlined below, the following complications will be included in the data collection follow up sheets: angular deformity, revision surgery, time until return to sports, hospital stay, failure/incomplete epiphysiodesis, time until weight bearing, infection, use of aid, number of days using the aid, and osteochondral damage.
• Medical Costs [ Time Frame: 5 years (end of study) ]
  Costs will be collected through hospital administration. In hospital costs and outpatients costs will be included. Indirect costs, such as lost days of parental work will not be considered. Only costs from the United States centers in this protocol will be assessed.
• Operative Outcomes [ Time Frame: intra-operative ]
  radiation, total time during surgery, skin dose, blood loss, surgeon experience, epiphysiodesis technique, fluoroscopy time
• Radiographic Assessments [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months ]
  Mechanical Tibial-Femoral Angle, Mechanical Axis Deviation, mLDFA, MPTA, PPTA

Original Secondary Outcome:

• Change in Physeal Growth [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 year ]
  Distance between tantalum beads.
• Time to Baseline Pain [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 year. ]
  Measured by VAS pain
• Quality of Life [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years ]
  PODCI
• Length of Hospital Stay [ Time Frame: An expected average of 2 days ]
  participants will be followed for the duration of hospital stay (discharge date - admission date)
• Number of Days Non-weight Bearing [ Time Frame: 2 weeks, 6 weeks, 3 months ]
  Documenting the number of days patient did not used weight bearing aids, such as crutches and wheelchairs.
• Number of Days with Modified Weight Bearing [ Time Frame: 2 weeks, 6 weeks, 3 months ]
  Documenting the number of days the patient used crutches or other weight bearing accessories.
• Need for Splint or Cast [ Time Frame: 2 weeks, 6 weeks, 3 months ]
  Documenting days worn.
• Days Until Return to Sports [ Time Frame: 2 weeks, 6 weeks, 3 months ]
  Documenting how many days elapsed before the patient returned to sports. This information will be recorded in a post-operative pain and function diary. Return to sports is typically surgeon driven, but timing for return to sports is not standardized in clinical practice. In the current study patients will be allowed to return to sports when pain free, no longer limping and strength is equivalent to the non-operative side
• Need for Secondary Surgery [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 years, 2 yea ]
  Assessed in follow up clinical visits and documented in clinical records
• Physical Activity Level [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years ]
  Pediatric activity scale assessment measured by HSS Pedi-FABS.
• Knee Function [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years. ]
  Knee function measured by Pedi-IKDC
• Complications [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years ]
  Complications will be tracked for two years post surgery. Due to previous research, which is outlined below, the following complications will be included in the data collection follow up sheets: angular deformity, revision surgery, time until return to sports, hospital stay, failure/incomplete epiphysiodesis, time until weight bearing, infection, use of aid, number of days using the aid, and osteochondral damage.
• Medical Costs [ Time Frame: 4 years (end of study) ]
  Costs will be collected through hospital administration. In hospital costs and outpatients costs will be included. Indirect costs, such as lost days of parental work will not be considered. Only costs from the United States centers in this protocol will be assessed.
• Operative Outcomes [ Time Frame: intra-operative ]
  radiation, total time during surgery, skin dose, blood loss, surgeon experience, epiphysiodesis technique

Dates:
Date Received: June 26, 2014
Date Started: June 2015
Date Completion: June 2019
Last Updated: April 20, 2017
Last Verified: April 2017