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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397383
• Other study ID #: 10014
• Status: Completed
• Phase: N/A
• First received: July 15, 2011
• Last updated: March 16, 2017
• Start date: March 2010
• Est. completion date: February 3, 2014

Study information

• Verified date: March 2017
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: February 3, 2014
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New york	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (9)

Birge SJ. Can falls and hip fracture be prevented in frail older adults? J Am Geriatr Soc. 1999 Oct;47(10):1265-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review. — View Citation

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. Review. — View Citation

Mowé M, Haug E, Bøhmer T. Low serum calcidiol concentration in older adults with reduced muscular function. J Am Geriatr Soc. 1999 Feb;47(2):220-6. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the within-patient change in WOMAC scores between groups.	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.	preoperatively, 6 week, 1 year, 2 year and 5 year post-THA
Secondary	The difference in the within-patient change of the performance-based tests between groups.	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.	preoperatively, 6 weeks, 1 year, 2 years, and 5 years post THA
Secondary	The difference in the within-patient change in SF-36 scores between groups	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.	preoperatively, 6 weeks, 1 year, 2 year, and 5 years postoperatively