Vitamin D and Functional Outcomes After Total Hip Arthroplasty (THA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by Hospital for Special Surgery, New York
Sponsor:
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01397383
First received: July 15, 2011
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

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.


Condition
Vitamin D Deficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Serum Vitamin D Level and the Short Term Functional Outcomes After Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Vitamin D deficiency
Patients with low serum vitamin D (25-hydroxy vitamin D < 32 ng/ml)
Control group
Patients with normal serum vitamin D level (serum 25-hydroxy vitamin D > 32 ng/ml)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients who are scheduled for primary total hip replacement will be identified at the preoperative visit.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397383

Contacts
Contact: Anas Saleh, MD 212.606.1604 saleha@hss.edu
Contact: Aasis Unnanuntana, MD 212.606.1604 unnanuntanaa@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New york, New York, United States, 10021
Contact: Thomas P Sculco, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Joseph M Lane, MD Hospital for Special Surgery, New York
Study Director: Aasis Unnanuntana, MD Hospital for speicial surgery
  More Information

Publications:

Responsible Party: Josehp M. Lane, MD/ Chief of metabolic bone disease unit., Hospital for Special Surgery
ClinicalTrials.gov Identifier: NCT01397383     History of Changes
Other Study ID Numbers: 10014
Study First Received: July 15, 2011
Last Updated: July 18, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 26, 2014