"Gait and Balance in Patients With SCFE"

NCT03326531 | Unknown DMC

• 1 other identifier: NL56402.068.16
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Slipped Capital Femoral Epiphysis (SCFE) treated with one screw in situ fixation results in an altered gait. It is thought that the protraction of the pelvis at the affected side, seen in patients with unilateral stable SCFE, is a compensatory mechanism to reduce out-toeing and thereby improve foot positioning during gait. This study will evaluate this hypothesis since only a few studies are conducted evaluating gait in treated SCFE. It is also thought that this pathology results in an impaired balance. Computer Assisted Rehabilitation Environment (CAREN) will be used to investigate these two questions.

Conditions

Slipped Capital Femoral Epiphyses

Outcome Measures

Primary Outcomes (1)

• Joint range of motion

  Range of motion (i.e. maximal angle minus minimal angle in degrees) of the pelvis, hip, knee and ankle of the affected and unaffected side in degrees.

  During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).

Secondary Outcomes (12)

• Absolute joint angles

  During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).

• Margins of Stability

  During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).

• Muscle activation patterns

  During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).

• Gait velocity

  During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).

• Hip Injury and Osteoarthritis Outcome Score

  One minute before the start of the test on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).

Interventions

Not applicable for this study OTHER

Not applicable for this study

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We expect that no major deviations in gait pattern occur later than 6 months after the intervention and therefore, a stable gait pattern is presented 6 months postoperatively. This expectation is made based on clinical experience, in which gait is often affected during these first 6 months after the intervention due to pain, a long non-weightbearing period of the leg in the postoperative phase and rehabilitation. After these six months no further deviations in gait pattern were expected and a stable, compensating gait pattern is observed and patients will be analysed between 6 months till 10 years postoperatively.

You may qualify if:

• Aged between 8 and 21 years.
• Unilateral stable SCFE, with clinical and radiological confirmation and lateral slip angles ranging from mild (LSA \<30°), moderate (LSA 30°-50°) to severe (LSA \>50°) based on the method of Southwick.
• Treatment of the slip with single screw in situ fixation in the last ten years, with no evidence of major complications related to the procedure like chondrolysis, avascular necrosis and infection or slip progression. Follow up at our institution for at least one year.
• Ability to walk 30 minutes without aid.
• Is able to speak, read and write the Dutch language

You may not qualify if:

• Clinical or radiological evidence of a contralateral slip or an endocrinopathy as underlying cause of SCFE.
• Revision surgery.
• Other pathology leading to gait alterations.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6202AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Epiphyses, Slipped

Central Study Contacts

Adhiambo M. Witlox, PhD, MD

CONTACT

+31433875038; ma.witlox@mumc.nl

Jasper Stevens, MD, PhD-candidate

CONTACT

+31433875038; jasper.stevens@mumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 31, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 17, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)