History of Changes for Study: NCT01397383

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

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			July 18, 2011	None (earliest Version on record)
2			March 16, 2017	Recruitment Status, Study Status, Contacts/Locations, Sponsor/Collaborators and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	10014
Brief Title:	Vitamin D and Functional Outcomes After Total Hip Arthroplasty (THA)
Official Title:	The Effect of Serum Vitamin D Level and the Short Term Functional Outcomes After Total Hip Arthroplasty
Secondary IDs:

Study Status


Record Verification:	July 2011
Overall Status:	Recruiting
Study Start:	March 2010
Primary Completion:	March 2015 [Anticipated]
Study Completion:	March 2015 [Anticipated]

First Submitted:	July 15, 2011
First Submitted that Met QC Criteria:	July 18, 2011
First Posted:	July 19, 2011 [Estimate]

Last Update Submitted that Met QC Criteria:	July 18, 2011
Last Update Posted:	July 19, 2011 [Estimate]

Sponsor/Collaborators


Sponsor:	Hospital for Special Surgery, New York
Responsible Party:
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

Brief 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.

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.

Conditions


Conditions:	Vitamin D Deficiency
Keywords:

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	200 [Anticipated]
Number of Groups/Cohorts	2

Groups and Interventions

Groups/Cohorts	Interventions
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)

Outcome Measures


Primary Outcome Measures:
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 Outcome Measures:
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.

Eligibility


Study Population:	Patients who are scheduled for primary total hip replacement will be identified at the preoperative visit.
Sampling Method:	Probability Sample
Minimum Age:	40 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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/Locations


Central Contact Person:	Anas Saleh, MD Telephone: 212.606.1604 Email: saleha@hss.edu
Central Contact Backup:	Aasis Unnanuntana, MD Telephone: 212.606.1604 Email: unnanuntanaa@hss.edu
Study Officials:	Joseph M Lane, MD Principal Investigator Hospital for Special Surgery, New York
	Aasis Unnanuntana, MD Study Director Hospital for speicial surgery
Locations:	United States, New York
	Hospital for Special Surgery [Recruiting] New york, New York, United States, 10021 Contact:Contact: Thomas P Sculco, MD

IPDSharing


Plan to Share IPD:

References


Citations:	Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available. PubMed 17634462
	Janssen HC, Samson MM, Verhaar HJ. Vitamin D deficiency, muscle function, and falls in elderly people. Am J Clin Nutr. 2002 Apr;75(4):611-5. doi: 10.1093/ajcn/75.4.611. PubMed 11916748
	Stein MS, Wark JD, Scherer SC, Walton SL, Chick P, Di Carlantonio M, Zajac JD, Flicker L. Falls relate to vitamin D and parathyroid hormone in an Australian nursing home and hostel. J Am Geriatr Soc. 1999 Oct;47(10):1195-201. doi: 10.1111/j.1532-5415.1999.tb05199.x. PubMed 10522952
	Birge SJ. Can falls and hip fracture be prevented in frail older adults? J Am Geriatr Soc. 1999 Oct;47(10):1265-6. doi: 10.1111/j.1532-5415.1999.tb05212.x. No abstract available. PubMed 10522964
	Bischoff HA, Stahelin HB, Urscheler N, Ehrsam R, Vonthein R, Perrig-Chiello P, Tyndall A, Theiler R. Muscle strength in the elderly: its relation to vitamin D metabolites. Arch Phys Med Rehabil. 1999 Jan;80(1):54-8. doi: 10.1016/s0003-9993(99)90307-6. PubMed 9915372
	Mowe M, Haug E, Bohmer T. Low serum calcidiol concentration in older adults with reduced muscular function. J Am Geriatr Soc. 1999 Feb;47(2):220-6. doi: 10.1111/j.1532-5415.1999.tb04581.x. PubMed 9988294
	Bischoff-Ferrari HA, Dietrich T, Orav EJ, Dawson-Hughes B. Positive association between 25-hydroxy vitamin D levels and bone mineral density: a population-based study of younger and older adults. Am J Med. 2004 May 1;116(9):634-9. doi: 10.1016/j.amjmed.2003.12.029. No abstract available. PubMed 15093761
	Gloth FM 3rd, Smith CE, Hollis BW, Tobin JD. Functional improvement with vitamin D replenishment in a cohort of frail, vitamin D-deficient older people. J Am Geriatr Soc. 1995 Nov;43(11):1269-71. doi: 10.1111/j.1532-5415.1995.tb07404.x. PubMed 7594162
	Verhaar HJ, Samson MM, Jansen PA, de Vreede PL, Manten JW, Duursma SA. Muscle strength, functional mobility and vitamin D in older women. Aging (Milano). 2000 Dec;12(6):455-60. doi: 10.1007/BF03339877. PubMed 11211956
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