Last reviewed · How we verify
NCT05527197
Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.
NA trial testing Lapiplasty in Hallux Valgus in 31 participants. Completed in 30 August 2023.
30 August 2023
Quick facts
| Lead sponsor | Midwest Bunion Center, LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 31 |
| Start date | 29 March 2022 |
| Primary completion | 30 August 2023 |
| Estimated completion | 30 August 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lapiplasty
Conditions studied
- Hallux Valgus — all drugs for Hallux Valgus →
Sponsor
Midwest Bunion Center, LLC
Who can join
Adults 18 to 80, any sex, with Hallux Valgus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of the study is to gather sufficient patient data to assess real world postoperative function after a first metatarsophalangeal (MTP) joint arthrodesis done in conjunction with first tarsometatarsal arthrodesis (TMT) (double fusion). Many studies have demonstrated the success of a first MTP joint arthrodesis in eliminating pain and reducing the intermetatarsal angle. Very little research has been published to assess the outcomes of double arthrodesis. Limited research has specifically assessed patients' everyday function and gait following MTP arthrodesis and no studies are available to assess real world function following double arthrodesis. More data that includes patient reported function during activities of daily living is needed to understand the benefits and draw backs of combined first MTP/TMT joint arthrodesis used to treat and correct first ray deformity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05527197
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lapiplasty
Trials testing the same drug.
- NCT03740282 — Early Weight-Bearing After the Lapiplasty Procedure · NA · active not recruiting
Other recruiting trials for Hallux Valgus
Currently open trials in the same condition.
- NCT07267156 — Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery · NA · recruiting
- NCT07378917 — Orthotic Impact on MTP Alignment in Hallux Valgus · NA · recruiting
- NCT06185608 — The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks · NA · recruiting
- NCT06874517 — Second Toe Length and Hallux Valgus: Greek vs. Egyptian Foot · recruiting
- NCT06541119 — Effect of Selective Strengthening of Peroneus Longus on Pain , Joint Alignment and Foot Function in Hallux Valgus · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05527197 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Midwest Bunion Center, LLC
- Last refreshed: 23 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05527197.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing