Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Randomized Control Trial Comparing Short-term Outcomes After Direct Anterior and SuperPATH Approaches

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746925
• Other study ID #: SuperPATH
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2019
• Est. completion date: April 7, 2023

Study information

• Verified date: August 2022
• Source: Ottawa Hospital Research Institute
• Contact: Wade Gofton, MD, FRCSC
• Phone: 613-798-5555
• Email: wgofton[@]ottawahospital.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study involves comparing the outcomes after using the Direct Anterior Approach (DAA) and the Supercapsular Percutaneously Assisted Total Hip (SuperPATH) approach. These are two approaches to hip replacement that both replace hips without cutting any muscles. DAA approach has been used for many years, but it has a high learning curve and can be difficult for doctors to use, it is however linked with fewer complications when performed by an experienced doctor. SuperPATH is a newer technique which has been shown in studies to be adopted with less complications even during the learning phase. It also shows cost-saving results, showing a reduced length of stay for patients and better 30-day readmission rates. There is pressure on surgeons, from both patients and administration to use techniques that spare tissue, offer early functionality without compromising long-term outcomes. The SuperPATH can meet this benchmark but uptake has been slow, the investigators believe that it is due to the learning curve shown by this approach. The senior surgeon at The Ottawa Hospital is experienced in both techniques, using a trial the investigators can compare the two techniques and help encourage surgeons to change to a procedure that has demonstrated a low complication profile.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 7, 2023
• Est. primary completion date: January 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing unilateral THA
• Over 18 years of age and below 80
• Subject is willing and able to complete required study visits and assessments
• Subject is willing to sign the approved informed consent form

Exclusion Criteria:

• Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0kg/m2 and 102.0cm, respectively for men, and 35.0kg/m2 and 88.0cm, respectively for women at screening
• Subject is currently enrolled in another clinical investigation related to lower limbs, which could affect the endpoints of this protocol
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• Subject is currently incarcerated or has impending incarceration
• Previous hip surgery or infection on ipsilateral hip

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Procedure:
• Direct Anterior Approach (DAA)
Direct Anterior Approach surgery to replace the hip.
• SuperPATH
SuperPATH approach surgery to replace the hip.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	MicroPort Orthopedics Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (21)

Alecci V, Valente M, Crucil M, Minerva M, Pellegrino CM, Sabbadini DD. Comparison of primary total hip replacements performed with a direct anterior approach versus the standard lateral approach: perioperative findings. J Orthop Traumatol. 2011 Sep;12(3):123-9. doi: 10.1007/s10195-011-0144-0. Epub 2011 Jul 12. — View Citation

Anterior Total Hip Arthroplasty Collaborative Investigators, Bhandari M, Matta JM, Dodgin D, Clark C, Kregor P, Bradley G, Little L. Outcomes following the single-incision anterior approach to total hip arthroplasty: a multicenter observational study. Orthop Clin North Am. 2009 Jul;40(3):329-42. doi: 10.1016/j.ocl.2009.03.001. — View Citation

Bal BS, Vallurupalli S. Minimally invasive total hip arthroplasty with the anterior approach. Indian J Orthop. 2008 Jul;42(3):301-8. doi: 10.4103/0019-5413.41853. — View Citation

Barrett WP, Turner SE, Leopold JP. Prospective randomized study of direct anterior vs postero-lateral approach for total hip arthroplasty. J Arthroplasty. 2013 Oct;28(9):1634-8. doi: 10.1016/j.arth.2013.01.034. Epub 2013 Mar 19. — View Citation

Chow J, Fitch DA. In-hospital costs for total hip replacement performed using the supercapsular percutaneously-assisted total hip replacement surgical technique. Int Orthop. 2017 Jun;41(6):1119-1123. doi: 10.1007/s00264-016-3327-8. Epub 2016 Nov 12. — View Citation

Chow J, Penenberg B, Murphy S. Modified micro-superior percutaneously-assisted total hip: early experiences & case reports. Curr Rev Musculoskelet Med. 2011 Sep;4(3):146-50. doi: 10.1007/s12178-011-9090-y. — View Citation

Della Torre PK, Fitch DA, Chow JC. Supercapsular percutaneously-assisted total hip arthroplasty: radiographic outcomes and surgical technique. Ann Transl Med. 2015 Aug;3(13):180. doi: 10.3978/j.issn.2305-5839.2015.08.04. — View Citation

Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000 Nov;27(11):2635-41. — View Citation

Goebel S, Steinert AF, Schillinger J, Eulert J, Broscheit J, Rudert M, Nöth U. Reduced postoperative pain in total hip arthroplasty after minimal-invasive anterior approach. Int Orthop. 2012 Mar;36(3):491-8. doi: 10.1007/s00264-011-1280-0. Epub 2011 May 25. — View Citation

Gofton W, Chow J, Olsen KD, Fitch DA. Thirty-day readmission rate and discharge status following total hip arthroplasty using the supercapsular percutaneously-assisted total hip surgical technique. Int Orthop. 2015 May;39(5):847-51. doi: 10.1007/s00264-014-2587-4. Epub 2014 Nov 16. — View Citation

Gofton W, Fitch DA. In-hospital cost comparison between the standard lateral and supercapsular percutaneously-assisted total hip surgical techniques for total hip replacement. Int Orthop. 2016 Mar;40(3):481-5. doi: 10.1007/s00264-015-2878-4. Epub 2015 Jul 9. — View Citation

Judet J, Judet H. [Anterior approach in total hip arthroplasty]. Presse Med. 1985 May 4;14(18):1031-3. French. — View Citation

Judge JO, Ounpuu S, Davis RB 3rd. Effects of age on the biomechanics and physiology of gait. Clin Geriatr Med. 1996 Nov;12(4):659-78. Review. — View Citation

Kennon RE, Keggi JM, Wetmore RS, Zatorski LE, Huo MH, Keggi KJ. Total hip arthroplasty through a minimally invasive anterior surgical approach. J Bone Joint Surg Am. 2003;85-A Suppl 4:39-48. — View Citation

Kerrigan DC, Todd MK, Della Croce U. Gender differences in joint biomechanics during walking: normative study in young adults. Am J Phys Med Rehabil. 1998 Jan-Feb;77(1):2-7. — View Citation

Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials. 1988 Dec;9(4):365-74. — View Citation

Meermans G, Konan S, Das R, Volpin A, Haddad FS. The direct anterior approach in total hip arthroplasty: a systematic review of the literature. Bone Joint J. 2017 Jun;99-B(6):732-740. doi: 10.1302/0301-620X.99B6.38053. Review. — View Citation

Nakata K, Nishikawa M, Yamamoto K, Hirota S, Yoshikawa H. A clinical comparative study of the direct anterior with mini-posterior approach: two consecutive series. J Arthroplasty. 2009 Aug;24(5):698-704. doi: 10.1016/j.arth.2008.04.012. Epub 2008 Jun 13. — View Citation

SMITH-PETERSEN MN, LARSON CB, et al. Complications of old fractures of the neck of the femur; results of treatment of vitallium-mold arthroplasty. J Bone Joint Surg Am. 1947 Jan;29(1):41-8. — View Citation

Varin D, Lamontagne M, Beaulé PE. Does the anterior approach for THA provide closer-to-normal lower-limb motion? J Arthroplasty. 2013 Sep;28(8):1401-7. doi: 10.1016/j.arth.2012.11.018. Epub 2013 Mar 16. — View Citation

Xie J, Zhang H, Wang L, Yao X, Pan Z, Jiang Q. Comparison of supercapsular percutaneously assisted approach total hip versus conventional posterior approach for total hip arthroplasty: a prospective, randomized controlled trial. J Orthop Surg Res. 2017 Sep 25;12(1):138. doi: 10.1186/s13018-017-0636-6. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)	This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Primary	Change in Gait analysis	This is done by a biomechanics lab for a subsection of 30 patients to test their hip movements.	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Secondary	Change in EQ-5D-5L	Generic health status. Each question is scored from 1-5, with 1 being no problems and 5 being severe problems. These scores are not aggregated. There are 5 questions, mobility, self-care, usual activities, pain and anxiety. The last page is asking the participant to self score their health that day out of 100.	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Secondary	Change in Pre-post Hgb	Checks blood oxygen level	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
Secondary	Change in Visual Analog Scale (VAS) Pain Score	To measure pain. This is a line with left most end representing no pain with the rightmost representing extreme pain. The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100. The line is 100mm long.	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.
Secondary	Change in Complication rates	Complications such as fractures that the participant experiences will be assessed	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Secondary	Readmission rates	Any readmission rates for the participant	3 months post-operatively
Secondary	Change in Timed-up-and-go (TUG)	The time it takes for the participant to get up from a chair walk 3 metres forward and back and sit back down	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Secondary	Change in Timed-Stair-Climb (TSC)	The time it takes for a participant to go up and down a flight of 10 stairs.	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Secondary	Change in Range of Motion (ROM)	IR and ER ROM at flexion and extension, this is measured using a goniometer (which is an instrument that measures an angle).	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.
Secondary	Change in X-rays (AP pelvis & lateral)	To check how their bones are faring in their hip area	This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.