Recruiting

Spinal Fusion

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03240484

Conditions

Spinal Fusion

Total Hip Replacement

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

X-Ray Imaging

Gait Analysis

Study Details

Brief summary:

The purpose of the study is to explore the long term functional status of people who have had both a spinal fusion procedure and a total hip replacement.

Conditions

Spinal Fusion

Total Hip Replacement

Study ID

NCT03240484

Start date

May 15, 2017

Status verified date

Mar, 2020

Completion date

Jun 1, 2021

Anticipated

Primary completion date

Nov 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willing to come to the Civic Campus for a surgical follow-up visit
  • Speaks English and/or French
  • Group 1 patients must have had a spine fusion (SF) and total hip arthroplasty (THA)
  • Group 2 patients must have had a total hip replacement (THA) and no history of spine fusion (SF)
  • Group 3 patients must have had a spine fusion (SF) and no history of total hip arthroplasty (THA)

Exclusion Criteria:

  • Patient does not meet all 'inclusion' criteria
  • Patient is unable to answer questionnaires
  • Unable to get x-rays for other medical reasons
  • Severe dementia

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

Spine Fusion and Total Hip Replacement

Any patient who has undergone spine fusion (SF) and total hip arthroplasty (THA). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.

Total Hip Replacement Group

Any patient who has had THA only (no spine fusion surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires. Patients may additionally be asked to participate in a gait analysis in a Human Movement Laboratory.

Spine Fusion Only Group

Any patient who has had spine fusion only (no hip replacement surgery). Patients will undergo x-ray imaging and complete functional assessment questionnaires.

Interventions

X-Ray Imaging

X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.

Gait Analysis

Certain patients may be asked to participate in a motion analysis procedure at the Human Movement Laboratory at the University of Ottawa. This procedure takes approximately 1.5 hours and you will only be asked to participate in the motion analysis procedure once. Participants will change into a custom-designed tight body suit, which has reflective markers on its surface for infrared video capture. Participants will then have pairs of surface electromyography (EMG) electrodes placed on certain areas of the skin on the legs and on the back. Wearing the EMG electrodes and marker suit, participants will perform 5 trials of walking on a level walkway, walking up and down a 3-step staircase, sitting from a standing position, and standing from a seated position.

Primary outcome measure

  • Implant positioning [ Time Frame: 6months or greater post-operative ]

Central Contacts and Locations

Central contacts

Locations

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1Y4E9

Contacts

Research Manager

613-737-8920

Principal Investigator:

Wade Gofton, MD FRCSC MEd

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 30, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2020-03-30.