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

NCT03746925 | Unknown DMC

• 1 other identifier: SuperPATH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

DAA; SuperPATH; Direct Anterior Approach; THA

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (9)

• Change in EQ-5D-5L

  This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.

• Change in Pre-post Hgb

  This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.

• Change in Visual Analog Scale (VAS) Pain Score

  This is from baseline (can be measured anytime to a maximum of one month before surgery) to 2 weeks post-operatively.

• Change in Complication rates

  This is from baseline (can be measured anytime to a maximum of one month before surgery) to 12 months post-operatively.

• Readmission rates

  3 months post-operatively

Study Arms (2)

Direct Anterior Approach (DAA)

ACTIVE COMPARATOR

Direct Anterior Approach surgery to replace the hip.

Procedure: Direct Anterior Approach (DAA)

SuperPATH

EXPERIMENTAL

SuperPATH approach surgery to replace the hip.

Procedure: SuperPATH

Interventions

Direct Anterior Approach (DAA) PROCEDURE

Direct Anterior Approach surgery to replace the hip.

Direct Anterior Approach (DAA)

SuperPATH PROCEDURE

SuperPATH approach surgery to replace the hip.

SuperPATH

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• MicroPort Orthopedics Inc.: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Related Publications (21)

• 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.

  PMID: 21789576 BACKGROUND

• 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.

  PMID: 26366397 BACKGROUND

• 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.

  PMID: 25398472 BACKGROUND

• 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.

  PMID: 27838761 BACKGROUND

• 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. No abstract available.

  PMID: 20284684 BACKGROUND

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

  PMID: 3158949 BACKGROUND

• 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. doi: 10.2106/00004623-200300004-00005. No abstract available.

  PMID: 14652392 BACKGROUND

• 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.

  PMID: 19753156 BACKGROUND

• 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.

  PMID: 23523485 BACKGROUND

• Goebel S, Steinert AF, Schillinger J, Eulert J, Broscheit J, Rudert M, Noth 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.

  PMID: 21611823 BACKGROUND

• 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.

  PMID: 21748384 BACKGROUND

• 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.

  PMID: 18555653 BACKGROUND

• 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.

  PMID: 19576400 BACKGROUND

• 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.

  PMID: 28946892 BACKGROUND

• 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.

  PMID: 28566391 BACKGROUND

• Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials. 1988 Dec;9(4):365-74. doi: 10.1016/0197-2456(88)90049-9.

  PMID: 3203526 BACKGROUND

• 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.

  PMID: 11093446 BACKGROUND

• 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.

  PMID: 26156723 BACKGROUND

• Varin D, Lamontagne M, Beaule 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.

  PMID: 23507070 BACKGROUND

• 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. doi: 10.1097/00002060-199801000-00002.

  PMID: 9482373 BACKGROUND

• 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.

  PMID: 8890109 BACKGROUND

Study Officials

• Wade Gofton, MD, FRCSC

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wade Gofton, MD, FRCSC

CONTACT

613-798-5555; wgofton@ottawahospital.on.ca

Meaghan Dufresne

CONTACT

613-737-8899; meadufresne@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a 2 group, parallel study where they will be randomized into one of the two groups. One will receive SuperPATH approach and the other will receive DAA.

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 20, 2018
• Study Start: September 7, 2019
• Primary Completion: January 7, 2023
• Study Completion: April 7, 2023
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)