NCT07851597

Brief Summary

This study intends to analyze the healing process of the hip muscle system and to evaluate the functional recovery score after performing a cemented primary THA for osteoarthritis (OA).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Mar 2021Dec 2028

Study Start

First participant enrolled

March 1, 2021

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

7.8 years

First QC Date

September 18, 2026

Last Update Submit

September 24, 2026

Conditions

Hip Arthroplasty

Outcome Measures

Primary Outcomes (3)

  • Hip abduction and external rotation strength in THA using direct lateral approach

    Hip abduction and external rotation muscle strength following THA using a direct lateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the direct lateral approach, strength outcomes will be compared according to postoperative gluteus medius tendon healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.

    Muscle strength preoperatively, at 3 months and 1 year after surgery.

  • Hip abduction and external rotation strength in THA using posterolateral approach

    Hip abduction and external rotation muscle strength following THA using a posterolateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the posterolateral approach, strength outcomes will be compared according to postoperative piriformis healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.

    Muscle strength preoperatively, at 3 months and 1 year after surgery.

  • Patient experiences based on interviews.

    A qualitative content analysis will be performed to explore patients' experiences of the undergoing surgical procedure and the rehabilitation period, including thoughts, concerns, emotions, and expectations related to recovery and the social environment.

    Interview 1 year after surgery.

Secondary Outcomes (4)

  • Hip abduction and external rotation strength in THA using direct lateral or posterolateral approach

    Muscle strength preoperatively, at 3 months and 1 year after surgery.

  • Clinical score evaluation using Harris Hip Score (HHS) inquiry.

    HHS preoperatively, at 6 weeks and 1 year after surgery.

  • Presence of Trendelenburg gait on clinical examination

    Preoperatively, at 6 weeks and 1 year after surgery.

  • Comparison of patient health satisfaction as defined with the inquiry SF-36.

    SF-36 preoperatively, at 3 months and 1 year after surgery.

Study Arms (2)

Direct lateral incision

ACTIVE COMPARATOR
Procedure: Total hip arthroplasty

Posterolateral incision

ACTIVE COMPARATOR
Procedure: Total hip arthroplasty

Interventions

Total hip arthroplastyPROCEDURE

Marking of surgically detached tendons with metall markers. Radiostereometric analysis of the migration of the metall markers in different time points after surgery to evaluate healing or no healing of the tendons.

Direct lateral incisionPosterolateral incision

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hip osteoarthritis as indication for THA surgery
  • use of cemented prosthetic Components

You may not qualify if:

  • symptomatic osteoarthritis on the contralateral hip
  • neuromuscular disorder
  • dementia
  • BMI\>40
  • previous surgery on any hip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gävle hospital orthopaedic clinic

Gävle, Sweden

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Central Study Contacts

Dimitrios Sotiriou, Medical doctor

CONTACT

+46762810301dimitrios.sotiriou@regiongavleborg.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2026

First Posted

October 1, 2026

Study Start

March 1, 2021

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because of concerns regarding participant privacy and confidentiality. Only aggregated study results will be reported.

Locations

SE(1)