Conservative and Surgical Clubfoot Treatment: A Multi-Center Study

Principal investigator and project director: Peter Smith, M.D., Shriners Hospitals for Children – Chicago

Co-principal investigators: Gerald F. Harris, Ph.D., Shriners Hospitals for Children – Chicago and OREC (Marquette U/Medical College of Wisconsin); Xue-Cheng Liu, Ph.D., M.D., Medical College of Wisconsin; Fred Dietz, M.D., University of Iowa

Investigators: Sahar Hassani, M.S., Shriners Hospitals for Children – Chicago; Adam Graf, M.S., Shriners Hospitals for Children –

Objectives:
The study compares long-term effects of two methods of clubfoot treatment: 1) conservative Ponseti technique of manipulation and casting and 2) progressive surgical release. The protocol is designed to improve understanding of function of the clubfoot during adolescence/young adulthood as individuals enter the work force. The study will provide comparison with normal foot function. The study should also provide a better understanding of the variability of clubfoot pathology among the treated groups using patient satisfaction and self-perception, outcome measures and quantitative functional tests.

The correlation among functional instruments (AOFAS, ICSFG, GMFM, etc.) and quantitative measures will be evaluated. The degree of correlation among these patient-based outcomes and functional tools may greatly enhance our assessment capability of treatment intervention. This research should bring insight into methods of evaluating outcomes and function and comparing the effects of different treatments.

Methods:
Ninety-six people (male and female), ages 18-23, will be tested. Forty-eight will be recruited from a pool of treated clubfoot candidates treated during the years 1982 to 1987. Of these 48, half will have been treated by Shriners Hospitals for Children – Chicago with progressive surgical treatment, and half will have been treated by the University of Iowa with conservative treatment-casting and manipulation. Forty-eight matched controls with normal lower extremity function and gait will also be tested.

Patients and matched controls to make a one-time visit. Clubfoot patients will be evaluated by the surgeon and physical therapist using the AOFAS hindfoot and mid-foot scores, ICFSG, and the GMFM. Both the clubfoot and matched controls will undergo a motion analysis study (gait and foot and ankle), radiological assessment, postural stability evaluation, and strength testing. The following examinations/ questionnaires will be performed: International Pain Scale Assessment, Functional Mobility Scale (FMS), and Gillette Functional Assessment Questionnaire (FAQ).