Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies (RetroCone)

Retrospective Study About the Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty for Osteoarthritis Due to Congenital Hip Pathologies

A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.

Study Overview

• Status: Completed
• Conditions: Prosthesis Survival; Dysplasia; Hip
• Intervention / Treatment: Device: Conical tapered stem

Detailed Description

Congenital hip pathologies may severely alter the local anatomy of the hip, making total hip arthroplasty (THA) due to osteoarthritis after congenital hip pathologies challenging. While it seems that congenital hip pathologies did not significantly influence the outcomes when compared to THA after osteoarthritis, the choice of implant was demonstrated to impact the survival rates of the THA after congenital hip pathologies.

To date, no guidelines exist about the correct choice of hip implant in congenital hip pathologies: only mid-term case series are available. Conical tapered stems have been frequently suggested for the most difficult cases.

The aim of this study is to describe the survival rates and the long-term clinical and radiological outcome of conical tapered stems in THAs after congenital hip pathologies.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

retrospective, consecutive adult population treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies.

Description

Inclusion Criteria:

• Symptomatic hip osteoarthritis due to congenital hip pathologies
• Consecutive population with a minimum follow-up of 2 years
• Cementless total hip arthroplasty with conical tapered stem
• Pre-operative planning using CT
• Complete clinical and radiographic assessment

Exclusion Criteria:

• Other type of hip osteoarthritis
• Other type of implants
• Inadequate pre-operative planning (eg: no CT)
• Incomplete clinical and radiographic assessment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Congenital hip pathologies; Conical tapered stem for osteoarthritis due to congenital hip pathologies	Device: Conical tapered stem; Implantation of conical tapered stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score	Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.	15 months
Survival Rate	Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.	15 months
Radiographic Cup Osseointegration	Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).	15 months
Radiographic Stem Osseointegration	Osseointegrated stems described according to Engh's criteria	15 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Study Director: Francesco Traina, Prof, IRCCS Istituto Ortopedico Rizzoli, Bologna, ITaly

Publications and helpful links

General Publications

• Greber EM, Pelt CE, Gililland JM, Anderson MB, Erickson JA, Peters CL. Challenges in Total Hip Arthroplasty in the Setting of Developmental Dysplasia of the Hip. J Arthroplasty. 2017 Sep;32(9S):S38-S44. doi: 10.1016/j.arth.2017.02.024. Epub 2017 Feb 22.
• Perry KI, Berry DJ. Femoral considerations for total hip replacement in hip dysplasia. Orthop Clin North Am. 2012 Jul;43(3):377-86. doi: 10.1016/j.ocl.2012.05.010.
• Argenson JN, Flecher X, Parratte S, Aubaniac JM. Anatomy of the dysplastic hip and consequences for total hip arthroplasty. Clin Orthop Relat Res. 2007 Dec;465:40-5. doi: 10.1097/BLO.0b013e3181576052.
• Pak P, de Steiger R. Cone femoral prosthesis for osteoarthritis of the hip with femoral dysplasia. J Orthop Surg (Hong Kong). 2008 Aug;16(2):206-10. doi: 10.1177/230949900801600216.
• Taniguchi N, Jinno T, Koga D, Hagino T, Okawa A, Haro H. Cementless Hip Stem Anteversion in the Dysplastic Hip: A Comparison of Tapered Wedge vs Metaphyseal Filling. J Arthroplasty. 2017 May;32(5):1547-1552. doi: 10.1016/j.arth.2016.12.020. Epub 2016 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 2, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: 589/2020/Oss/IOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No