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NCT01397383 · ClinicalTrials.gov registry record
Vitamin D and Functional Outcomes After Total Hip Arthroplasty (THA)
A clinical trial, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- 219
- Enrollment target
NCT01397383: Completed study, sponsored by Hospital for Special Surgery, New York.
NCT01397383 is a clinical trial that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 219 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397383 has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- 219 participants
- Enrollment target
Study Summary
The investigators would like to evaluate the effect of serum 25-hydroxy vitamin D level on post-operative short-term functional outcomes after total hip arthroplasty (THA). Hypothesis: Patients with low serum vitamin D level will have less within-patient improvement in pre- to 6 week, 1 year, 2 year and 5 year post THA WOMAC scores, SF-36 scores, and performance-based tests(get up and go test and 2 minute walking test) compared to patients who do not have a low vitamin D levels. Also, Patients with low serum vitamin D level will have a higher rate of postoperative thigh pain or periprosthetic fracture.
Primary Outcome
The primary outcome will be the difference in the within-patient change in pre- to 6 week, 1 year, 2 year and 5 year post-THA WOMAC scores between groups. A clinically important difference between groups will be considered as 5 points change in the functional component of WOMAC. WOMAC is obtained as part of the HOOS questionnaire which is routinely used in all patients that are scheduled for total joint replacements at Hospital for Special Surgery. We will obtain this score at both pre-operativ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-02-03 |
What the finished NCT01397383 record still lists
NCT01397383 is an observational study that tracks outcomes without assigning an intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01397383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01397383 about?
NCT01397383 is a clinical study titled "Vitamin D and Functional Outcomes After Total Hip Arthroplasty (THA)". The investigators would like to evaluate the effect of serum 25-hydroxy vitamin D level on post-operative short-term functional outcomes after total hip arthroplasty (THA). Hypothesis: Patients with low serum vitamin D level will have less within-patient improvement in pre- to 6 week, 1 year, 2 yea...
What is the current status of trial NCT01397383?
This trial is currently completed. The enrollment target is 219 participants. The study started on 2010-03. Estimated completion is 2014-02-03.
Who is sponsoring clinical trial NCT01397383?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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