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

• Sponsor: Istituto Ortopedico Rizzoli (Other)
• Overall Status: Completed
• CT.gov ID: NCT04748458
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dysplasia; Hip; Prosthesis Survival	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 Design

• Study Type: Observational
• Actual Enrollment: 85 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Study About the Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty for Osteoarthritis Due to Congenital Hip Pathologies
• Actual Study Start Date: Jul 17, 2020
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Oct 2, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Harris Hip Score [15 months]

   Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.

2. Survival Rate [15 months]

   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.

3. Radiographic Cup Osseointegration [15 months]

   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).

4. Radiographic Stem Osseointegration [15 months]

   Osseointegrated stems described according to Engh's criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy	Bologna		Italy	40136

Sponsors and Collaborators

• Istituto Ortopedico Rizzoli

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 18, 2022

More Information

Publications

None provided.

• Responsible Party: Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT04748458
• Other Study ID Numbers: 589/2020/Oss/IOR
• First Posted: Feb 10, 2021
• Last Update Posted: Mar 22, 2022
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prosthesis Failure

Study Results

Participant Flow

Arm/Group Title	Congenital Hip Pathologies
Arm/Group Description	Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Period Title: Overall Study
STARTED	85
COMPLETED	85
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Congenital Hip Pathologies
Arm/Group Description	Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Overall Participants	85
Overall hip	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.9 (11.5)
Sex: Female, Male (Count of Participants)
Female	64 75.3%
Male	21 24.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	85 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Italy	85 100%
Crowe I (hip) [Count of Units]
Count of Units [hip]	46
Crowe II (hip) [Count of Units]
Count of Units [hip]	30
Crowe III (hip) [Count of Units]
Count of Units [hip]	14
Crowe IV (hip) [Count of Units]
Count of Units [hip]	10

Outcome Measures

1. Primary Outcome

Title	Harris Hip Score
Description	Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.
Time Frame	15 months

Outcome Measure Data

Analysis Population Description

Total hip arthroplasties with a Wagner Cone implant in dysplasia

Arm/Group Title	Congenital Hip Pathologies
Arm/Group Description	Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Measure Participants	85
Measure hip	100
Mean (Standard Deviation) [points]	89.8 (6.8)

2. Primary Outcome

Title	Survival Rate
Description	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.
Time Frame	15 months

Outcome Measure Data

Analysis Population Description

Total hip arthroplasties with a Wagner Cone implant in dysplasia

Arm/Group Title	Congenital Hip Pathologies
Arm/Group Description	Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Measure Participants	85
Measure hip	100
Mean (95% Confidence Interval) [percentage of surviving hips]	98.9

3. Primary Outcome

Title	Radiographic Cup Osseointegration
Description	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).
Time Frame	15 months

Outcome Measure Data

Analysis Population Description

Total hip arthroplasties with a Wagner Cone implant in dysplasia

Arm/Group Title	Congenital Hip Pathologies
Arm/Group Description	Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Measure Participants	85
Measure hip	100
Count of Units [hip]	98

4. Primary Outcome

Title	Radiographic Stem Osseointegration
Description	Osseointegrated stems described according to Engh's criteria
Time Frame	15 months

Outcome Measure Data

Analysis Population Description

Total hip arthroplasties with a Wagner Cone implant in dysplasia

Arm/Group Title	Congenital Hip Pathologies
Arm/Group Description	Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Measure Participants	85
Measure hip	100
Count of Units [hip]	99

Adverse Events

Time Frame	15 months
Arm/Group Title	Congenital Hip Pathologies
Arm/Group Description	Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
All Cause Mortality
	Congenital Hip Pathologies
	Affected / at Risk (%)	# Events
Total	4/85 (4.7%)
Serious Adverse Events
	Congenital Hip Pathologies
	Affected / at Risk (%)	# Events
Total	0/85 (0%)
Other (Not Including Serious) Adverse Events
	Congenital Hip Pathologies
	Affected / at Risk (%)	# Events
Total	0/85 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.