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Completed

NCT Number: NCT01397383

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 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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

Vitamin D is an important nutrient to maintain both skeletal and non-skeletal function. In this study, we have 4 specific aims:

The primary aim of this prospective observational study is to compare the pre- to 6 week, 1 year, 2 year and 5 year post-THA within-patient change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores between patients who have a low preoperative serum vitamin D level and patients who do not have a low serum vitamin D level. Low serum vitamin D will be defined as serum 25-hydroxy vitamin D level less than 32 ng/ml.

The secondary aim is to compare the pre- to 6 week, 1 year, 2 year and 5 year post-THA within-patient change in performance-based tests (get up and go test, 2 minute walking test) between patients who have a low preoperative serum vitamin D level and patients who do not have a low serum vitamin D level.

The third aim is to compare the pre- to 6 week, 1 year, 2 year and 5 year post-THA within-patient change in Short-form 36 health survey (SF-36) scores between patients who have a low preoperative serum vitamin D level and patients who do not have a low serum vitamin D level.

The fourth aim is to compare the rate of postoperative fracture or thigh pain between patients who have a low preoperative serum vitamin D level and patients who do not have a low serum vitamin D level.

Postoperative thigh pain is defined as pain at the anterolateral aspect of mid thigh which corresponds to the level of the prosthetic stem tip. Thigh pain is characterized by pain in the start-up phase, diminishes during movement and is absent at rest.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between the ages of 40 and 100 years old, and are scheduled for primary total hip arthroplasty with two surgeons (Drs. Sculco and Cornell) at Hospital for Special Surgery.
  • Patients who have a serum 25-OH vitamin D drawn as part of their preoperative work-up.

Exclusion criteria

  • Bilateral one-stage total hip replacements
  • Patients who required a complex surgical procedure including extensive bone grafting, osteotomy, extensive soft tissue release, or a need of adjunctive internal fixation with cables, wires or plate
  • Those with serious medical co-morbidities that need adjusted rehabilitation protocol due to their medical problems
  • Those who require immediate postoperative revision due to dislocation, infection or component malalignment

Treatment and study plan

Primary outcomes

  1. The difference in the within-patient change in WOMAC scores between groups.

    Time frame: preoperatively, 6 week, 1 year, 2 year and 5 year post-THA

    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-operative screening and 6 week, 1 year, 2 year and 5 year after the surgery.

Secondary outcomes

  1. The difference in the within-patient change of the performance-based tests between groups.

    Time frame: preoperatively, 6 weeks, 1 year, 2 years, and 5 years post THA

    Secondary outcome will be the difference in the within-patient change of the performance-based tests (get up and go test and 2 minute walking test) between pre- and 6 week, 1 year, 2 year and 5 year post-THA.

  2. The difference in the within-patient change in SF-36 scores between groups

    Time frame: preoperatively, 6 weeks, 1 year, 2 year, and 5 years postoperatively

    Tertiary outcome will be the difference in the within-patient change in pre- to 6 week, 1 year, 2 year and 5 year post-THA SF-36 scores between groups Preoperative SF-36 is also included as part of the HOOS questionnaire.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

The Effect of Serum Vitamin D Level and the Short Term Functional Outcomes After Total Hip Arthroplasty

Important dates

Study start
2010
Primary completion
2011
Study completion
2014
First posted
Jul 19, 2011
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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